Quality assurance specialist jobs in Greenville, NC - 105 jobs
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Food Safety & Quality Assurance Supervisor-Retail
Butterball 4.4
Quality assurance specialist job in Mount Olive, NC
Guides the day-to-day operations of a team monitoring product attributes to assure product quality is at targeted levels of the customer product specifications. Ensures food safety, regulatory and company compliance, and compliance with all established safety procedures. Ensures all required checks and tests are performed within the plant as prescribed in the USDA regulations, Butterball LLC Policies, and the HACCP program. Responsible for retained product releases.
At Butterball, we exist to help people pass love on. As the most recognized name in turkey, the brand represents more than 60 years of cherished memories, providing quality, great tasting products that make meals something to celebrate every day. We proudly believe that life at Butterball means having a team who supports you, having the opportunity to grow personally and professionally, and making an impact on the health of others daily.
Whether you choose to work at one of our five (5) manufacturing facilities in NC, AR, MO, farms in AR, NC, and KS, corporate office in NC, IL, or in the field, we believe we have an opportunity for everyone to succeed. At Butterball, we believe in fostering a culture where every team member is valued, has the opportunity to grow professionally and contribute to our success. Join us in our Purpose and apply for an opportunity today!
Key Responsibilities
Supervises the day-to-day activities of a team of entry level individual contributors. Provides guidance, coaching, and support to ensure successful completion of tasks. Participates in HR activities such as hiring, terminations, performance management, goal setting, team member development, scheduling, etc. Enforces systems, policies, and procedures. Reviews and approves timecards.
Responsible for ensuring adherence to all food safety regulations and quality standards on the Plant floor(s), including contractor and construction projects. Provides coaching and follows up with technicians and operations to ensure compliance.
Assists with the development and implementation of policies, process control procedures and monitoring, and standard practices.
Troubleshoots plant quality, safety, and sanitation problems. Implements corrective actions to address and mitigate identified issues.
Promotes GMP (Good Manufacturing Practices) and Food safety across the organization. Provides coaching and training across the operation's teams as needed.
Works closely with USDA.
Reviews all paperwork to ensure proper procedures are followed. Investigates and escalates issues as appropriate.
Assists with facility, customer, and third-party audits and audit preparation. Responsible for daily SOP audits.
Participates in investigation of product failures and customer complaints. May provide recommended solution to management team.
Communicates with all levels of management to ensure they maintain control of the process.
Identifies opportunities and supports creation and implementation of plant processes and/or product improvement projects.
Maintains the technical expertise of team with recurring training in all areas with their functional area.
Minimum Qualifications (Educations & Experience)
High school diploma, GED, or equivalent
4+ years of relevant experience or the knowledge, skills, and abilities to succeed in the role
1+ year of leadership experience or the knowledge, skills, and abilities to succeed in the role
Experience in a food environment
Knowledge, Skills, and Abilities
Butterball Core Competencies
Caring about people, valuing contributions, and empowering to succeed is the Butterball Way. We recognize the value that different perspectives and cultures bring to Butterball and seek to create an environment where everyone can thrive. Everyone has a seat at the table and is expected to embody our core competencies:
Safety First: We put safety first. The health, safety, and well-being of our people, products, and turkeys is everyone's responsibility and everyone's jobs.
Integrity: We trust each other to do the right thing. We act with integrity and gain the confidence and trust of others through honesty, respect, and authenticity.
Stewardship: We take care of what matters. We are accountable to our commitments and take responsibility for the well-being of our teams, our quality, our customers, our business, our brand, and our communities. We are always answerable for our actions and those we lead.
Enthusiastic Attitudes: We create a climate where everyone feels they belong and can be engaged, every day. Where our people are enthusiastic and motivated to do their best and work together to make great things happen.
Continuous Improvement: We are committed to continuous improvement. We challenge ourselves and our company to constantly learn, develop, grow, improve, and innovate
Essential Knowledge, Skills, and Abilities
Ability to coach, develop, support, and guide a team with technical skills
Knowledgeable or ability to learn product specifications, plant quality procedures, and plant HACCP plan
Familiarity with GMPs, Food Safety, HACCP, USDA and SSOPs
Ability to draft reports and document procedures
Ability to perform a risk analysis
Good communication and interpersonal skills with the ability to effectively present information and respond to questions
Ability to apply basic math and calculate figures and amounts such as proportions, percentages, area, circumference, and volume
Ability to define problems, collect data, establish facts, and draw valid conclusions
Preferred Knowledge, Skills, and Abilities
Bachelor's degree in relevant field
Physical Demands
While performing the duties of this job, the employee may be regularly required to stand, sit, talk, hear, reach, stoop, kneel, and use hands and fingers to operate a computer, telephone, keyboard, and occasionally lift up to 15 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
Working Conditions
Work will be performed in a variety of conditions including a climate-controlled office environment(s) and in a manufacturing plant environment with varying conditions, such as cold areas, wet areas, warm areas, chemicals, and other site conditions. This position requires the individual to wear and work in personal protective equipment while in the manufacturing environment.
The noise level of the office environment is usually moderate; the noise level in the manufacturing environment may exceed 85 DBA and require hearing protection.
Occasional travel may be required.
Disclaimer
We embrace equal opportunity employment. Butterball is committed to the fair and impartial treatment of all employees and applicants for employment without regard to gender, age, race, religion, color, national origin, physical or mental disability, military/veteran status, sexual orientation, gender identity and expression, genetic information, marital status, parental status, pregnancy, or any other status protected by law.
This position is deemed Safety Sensitive for purposes of Butterball's Drug/Alcohol Screening & Testing Policy. Details will be provided to individuals who receive a conditional job offer, or upon request.
The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of what is required of personnel so classified. Furthermore, they do not imply or establish a contract for employment and are subject to change at the discretion of the employer.
$65k-81k yearly est. 1d ago
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QA Specialist III, Quality on the Floor (12-hour nights)
Thermo Fisher Scientific 4.6
Quality assurance specialist job in Greenville, NC
Work Schedule
12 hr shift/nights
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit *********************
GROUP/DIVISION SUMMARY
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
POSITION SUMMARY
In this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours are 6p - 6a, on a 2-2-3 rotation.
Key Responsibilities:
Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.
Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
Champions quality culture by aiding personnel in understanding application of policies and controls
Participates in RAPID event response and provides quality guidance for deviation events
Advances deviation events to the appropriate area and quality management
Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
Performs quality review and approval of deviation and change control of moderate to high complexity
Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
Performs quality batch record review
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives
Qualifications:
Bachelor's degree, preferably in technology, engineering or microbiology related field required.
5+ years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing required
Previous experience in pharmaceutical industry, preferably with QA oversight experience within an aseptic or steriles filling and manufacturing operation strongly preferred. Experience in other GMP environments may be considered (i.e. ISO 9001)
An equivalent combination of education and relevant experience may be considered.
Ability to capture data, analyze & troubleshoot process issues, equipment problems along with production leadership
Ability to troubleshoot process and equipment issues
Hard-working, demonstrated ownership & responsibility;
Ability to lead, support & empower a team/peers
Technical Writing experience
Professional certifications (ex: CQA) and training (Six Sigma) are a plus
Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
$87k-110k yearly est. Auto-Apply 37d ago
Quality Assurance Specialist
Pathways To Life 3.9
Quality assurance specialist job in Greenville, NC
The QA specialist is responsible for quality assurance and quality improvement across the entire agency. While this is a leadership position, all staff persons within the agency are expected to participate in activities to ensure the quality and ongoing improvement of services provided by the agency. The QA specialist is responsible for developing and implementing the agency's quality management system, including both its internal quality assurance and improvement activities. As an active member of the agency's leadership team, the QA specialist is expected to provide leadership in developing the agency's annual quality improvement plan and ensuring the effective implementation of policies and procedures for credentialing and supervision of staff, monitoring of services, assurance of the safety of individuals served and effective outcomes, review of adverse events and identification of improvement opportunities. The QA specialist is expected to take a leadership role in ensuring that the agency regularly uses input of staff and service recipients and aggregate data to identify issues and opportunities for improvement and to support decisions about members' care and the agency's direction. The QA specialist is also responsible for the development of collaborative relationships between the agency and MCOs in which the agency provides services through involvement in their communities' quality management initiatives.
ESSENTIAL DUTIES/FUNCTIONS:
Develop, revise and implement the agency's annual quality improvement/quality assurance and training plans and update quarterly.
Review agency performance, adverse events, quality of care and personal outcomes, through auditing, supervision plans, and annual reviews.
Ensure compliance with all documentation, staff qualifications, and other state, federal and accrediting body requirements for the services being delivered.
Ensuring the agency's compliance with accreditation standards and leading re-accreditation activities.
Oversee the completion and timely submission of NCTOPPS documentation, provide email notification regarding deadlines.
Conducts monthly program meetings for all sites; collect feedback via staff surveys, communicate changes and documents needs (trainings, supplies, staffing, etc)*
Collaborate with the Corporate Quality Assurance Team on the design, documentation, and implementation of various systems and forms that will be used to monitor all training requirements. *
Responsible for administering stakeholder, staff, and monitoring the completion of consumer survey completion and documentation.
Lead and/or assist with other operational tasks including, but not limited to, audits, deficiencies, incident reports and other QA data collection and analysis as requested by supervisor or other team members.
Ensure all monthly chart audits are completed per policy, responsible for the completion of corporate location chart audits.
Collecting documentation for all incident reports for sites.
Complete random calls to all crisis lines throughout the agency and document result. Report any non compliance with responses to test calls to the Chief Executive Officer.
Responsible for checking DMA and DHHS websites to ensure compliance with all requirements and keeping the organization aware of any upcoming changes.
Perform other task as requested by leadership team or CEO
CLINICAL DUTIES:
Initiate engagement with stakeholders such as Specialized Trainers and MCOs to foster increased outpatient service types within the agency (TFCBT, PCIT, DBT).
Engage in regular collaboration with Corporate Quality Team Members creating and facilitating clinical training curriculums to support quality service delivery measures.
Engage in direct clinical interventions and modeling as needed to support identified clinical staff and supervisees.
POSITIONS SUPERVISED: None
LEVEL OF EDUCATION/TRAINING/QUALIFICATIONS:
A Bachelor's Degree from an institution of higher learning accredited by an accrediting body recognized by the U.S. Department of Education in a field of health, behavioral health, rehabilitation, human services, human development, education, social sciences, criminal justice, administration, management, organizational development, information management, business, or a related field or discipline and three years of experience gathering and analyzing data for quality management, quality assurance or quality improvement for a human services provider agency, or an equivalent combination of training and experience; or
A Master's Degree from an institution of higher learning accredited by an accrediting body recognized by the U.S. Department of Education, in a field of health, behavioral health, rehabilitation, human services, human development, education, social sciences, criminal justice, administration, management, organizational development, information management, business, or a related field or discipline and one year of experience gathering and analyzing data for quality management, quality assurance or quality improvement for a human services provider agency or an equivalent combination of training and experience.
Ability to apply the concepts of customer service in the workplace. Ability to use good professional judgment and be detail oriented. Ability to work independently, with minimal direct supervision.
Excellent organizational, prioritization, and interpersonal communication skills. Excellent oral and written communication skills.
Ability to handle multiple tasks and meet critical deadlines. Ability to meet short and long-term goals and project deadlines.
Respect for the confidentiality of all communications required within job duties, including client/employee records and documents, and electronic transmission by voice, data, and wire.
Experience with multi-cultural/multi-lingual populations and multi-disciplinary teams.
Possesses a basic knowledge of all office equipment, including word processors, computers, fax, and copy machines, and a willingness to attend appropriate classes to increase knowledge as needed.
REQUIRED CERTIFICATION/LICENSE: None
PHYSICAL DEMANDS: Regularly walk, stand or stoop; occasionally lift, carry, push, pull or otherwise move objects weighing up to 25 pounds; and regularly drive a motor vehicle.
WORKING CONDITIONS:
Work is performed in an office or other environmentally controlled room; Work may expose employees to contagious or infectious diseases; Work may expose employees to dangerous and volatile situations; which could result in bodily injury.
** Candidate must be able to travel to GreenvilleNC when needed for site audits**
Who we are
Pathways to Life is a local wellness organization committed to helping individuals and families achieve wellness. We specialize in mental health, substance abuse, outpatient services, laboratory testing, medication management, and community and in-home mental health services for adults and children.
Since 2006, we have been providing quality services to our local communities through proven programs and treatment methods delivered by local and qualified professional staff who understand the importance of affecting positive change and restoring wellness in the lives of those we serve.
What we believe
At Pathways to Life, our mission is to foster continual growth in the lives of those we serve, our colleagues, our culturally diverse communities, and ourselves. Our efforts enhance recovery, wellness, self-determination, and independence by providing person-centered support, advocacy, and outreach efforts delivered with empathy and respect. Pathways prides itself on whole-person treatment, and we believe in providing our clients and staff with as many healthy resources as possible.
Pathways to Life, Inc. offers comprehensive compensation and benefits to full-time employees, including:
Competitive compensation with regular performance feedback.
Healthcare insurance, including medical, dental, and vision.
Paid time off.
Per diem and part-time options available.
If you are ready to make a real difference in the lives of the people we serve, please apply today to join our team. Pathways to Life, Inc. is an equal opportunity employer providing reasonable accommodation to qualified employees with disabilities protected by applicable laws, regulations, and ordinances.
Pathways to Life, Inc is an EEO Employer - M/F/Disability/Protected Veteran Status View all jobs at this company
$74k-92k yearly est. 60d+ ago
NDT (Level II) Quality Assurance 3rd shift
GE Vernova
Quality assurance specialist job in Greenville, NC
SummaryVernova Purpose GE Vernova is accelerating the path to more reliable, affordable, and sustainable energy, while helping our customers power economies and deliver the electricity that is vital to health, safety, security, and improved quality of life. Are you excited at the opportunity to electrify and decarbonize the world?Job Description
What you'll do:
Perform liquid penetrant inspections, magnetic particle inspections, and do other related nondestructive testing as required.
Perform in process and final quality assurance checks of assemblies, tools, components, fabrications, and parts using a wide variety of standard and special measuring gauges, devices and techniques.
Must attain Level II Certification for required NDT Techniques o Must be able to successfully complete Level II certification requirements including classroom work and relevancy exams.
Perform workstation audits as required
Perform other assigned duties
Perform all duties as part of a team
What you'll bring:
Minimum High School diploma / GED equivalent
Must successfully complete the Quality Assurance Operator Test
Must successfully pass required testing for NDT certification
Prior experience in Quality Operations
Must meet medical/physical Quality Assurance Operator requirements, with or without reasonable accommodation
Ability to work 3rd shift(11PM - 7 AM), with or without reasonable accommodation
Pay Rate: The pay for this position is $ 26.100 - $27.309. This position is also eligible for shift premium when you work on an off shift i.e. 2nd or 3rd shift. Plus $1.00 USD an hour on top of base pay. This posting is expected to close on October 27, 2025.
Benefits Available to You
GE Vernova employees rise to the challenge of building a world that works. In order to meet this mission, we provide varied, competitive benefits to help support our workforce: Our Culture | GE Vernova (gecareers.com)
Our compensation & benefits are designed to reward high performers and help you manage your personal and family needs. We offer a robust benefits package depending on your employment status and your national requirements.
A healthy, balanced lifestyle can mean different things to different people. We've created programs that support the way you live and work today.
GE Vernova invests to provide opportunities to grow your career by providing a path for continued on-the-job learning and development.
Inclusion
At GE Vernova, we believe in the value of your unique identity, background and experiences. We are committed to fostering an inclusive culture, where everyone feels empowered to do their best work because they feel accepted, respected and that they belong. Click here to learn more: **************************************************
About GE Vernova Gas Power
GE Vernova's Gas Power business engineers advanced, efficient natural gas-powered technologies and services, along with decarbonization solutions that aim to help electrify a lower carbon future. It is a global leader in gas turbines and power plant technologies and services with the industry's largest installed base
Additional Information
GE Vernova offers a great work environment, professional development, challenging careers, and competitive compensation. GE Vernova is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE Vernova will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Relocation Assistance Provided: No
$78k-104k yearly est. Auto-Apply 60d+ ago
QA Specialist, C&Q/CSV
8427-Janssen Cilag Manufacturing Legal Entity
Quality assurance specialist job in Wilson, NC
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Wilson, North Carolina, United States of America
:
The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina.
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Essential Job Duties and Responsibilities
This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities:
Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.
Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project.
Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP's, Work Instructions and any other technical document.
Review and approves validation protocols and reports (analytical, cleaning, process, etc.)
Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
Perform QA reviews of system impact assessments and categorization of equipment and utilities.
Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities.
Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements.
Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues.
Additional Job Duties and Responsibilities:
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance as required.
Minimum Qualification
Bachelor's degree in a scientific or engineering discipline is required.
Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators - as well as Process Equipment - Bioreactors, UF/DF, centrifuge, Chromatography systems.
Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation.
Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
Strong understanding of risk-based approaches to commissioning and qualification/validation.
Proficiency in technical writing for validation and quality documents.
Strong communication and interpersonal skills for cross-functional collaboration.
Other requirements
An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Proven ability to manage multiple priorities and work independently with minimal supervision.
Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
Ability to build and nurture strong and positive relationships.
The ability to work in a team environment and interact with all levels of the organization.
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
For additional general information on Company benefits, please go to: - *********************************************
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$79k-127.7k yearly Auto-Apply 8d ago
QA Specialist, C&Q/CSV
6120-Janssen Scientific Affairs Legal Entity
Quality assurance specialist job in Wilson, NC
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Wilson, North Carolina, United States of America
:
The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina.
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Essential Job Duties and Responsibilities
This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities:
Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.
Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project.
Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP's, Work Instructions and any other technical document.
Review and approves validation protocols and reports (analytical, cleaning, process, etc.)
Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
Perform QA reviews of system impact assessments and categorization of equipment and utilities.
Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities.
Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements.
Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues.
Additional Job Duties and Responsibilities:
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance as required.
Minimum Qualification
Bachelor's degree in a scientific or engineering discipline is required.
Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators - as well as Process Equipment - Bioreactors, UF/DF, centrifuge, Chromatography systems.
Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation.
Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
Strong understanding of risk-based approaches to commissioning and qualification/validation.
Proficiency in technical writing for validation and quality documents.
Strong communication and interpersonal skills for cross-functional collaboration.
Other requirements
An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Proven ability to manage multiple priorities and work independently with minimal supervision.
Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
Ability to build and nurture strong and positive relationships.
The ability to work in a team environment and interact with all levels of the organization.
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
For additional general information on Company benefits, please go to: - *********************************************
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$79k-127.7k yearly Auto-Apply 8d ago
Quality Assurance Specialist
TPG Inc. 4.2
Quality assurance specialist job in Rocky Mount, NC
Job Description
SUMMARY: Coordinate daily activity with the Production and Quality Team to provide necessary support from Quality Inspectors and mitigate suspect product from reaching all levels of customer.
DUTIES AND RESPONSIBILITIES:
Provide Training/Oversight of Quality Inspectors on a daily basis - provide feedback on performance and opportunities for improvement
Perform Receiving Inspection checks
Perform Line Verifications/Error Proofing Audits
Provide Training for Production Line Leads for Verification/Error Proofing task and documentation
Participate and oversee Safe Launch/Engineering Builds - provide training to team for completion of builds
Perform Production/Document Audits, including but not limited to, Layered Process Audits, Work Instruction Audits and Verification Audits.
Perform Daily/Weekly calibration verifications
Facilitate as a liaison with Production to address immediate needs/questions as an immediate resource
Performs other related duties as assigned by management.
SUPERVISORY RESPONSIBILITIES:
This job has no supervisory responsibilities.
QUALIFICATIONS:
High school diploma or general education degree (GED), or one to three months related experience and/or training, or equivalent combination of education and experience.
Computer skills required: Inventory Software; Microsoft Office Suite
Other skills required:
Ability to communicate effectively to multi-levels of Team
Excellent time management skills
Use of hand measurement tools
Basic math skills
COMPETENCIES:
Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Visionary Leadership - Displays passion and optimism; Inspires respect and trust; Mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
Frequently required to stand
Frequently required to walk
Occasionally required to sit
Occasionally required to utilize hand and finger dexterity
Occasionally required to climb, balance, bend, stoop, kneel or crawl
Frequently required to talk or hear
While performing the duties of this job, the noise level in the work environment is usually moderate
The employee must occasionally lift and /or move more than _10_ pounds
Specific vision abilities required by this job include: Close vision; Distance vision; Color vision; Peripheral vision; Depth perception and ability to adjust focus
$62k-101k yearly est. 10d ago
Quality Assurance Specialist, 2nd Shift
Prolec-Ge Waukesha, Inc.
Quality assurance specialist job in Goldsboro, NC
The Quality Specialist inspects critical subassemblies and audits results against specified requirements. Additionally, the Specialist helps the organization meet ISO standards in documentation and calibration requirements.
PRINCIPLE DUTIES AND RESPONSIBILITIES
Interfaces with supervision and shop personnel to ensure product and process integrity.
Audits all elements of the ISO standard across all functions. This requires process knowledge of Purchasing, Engineering, Manufacturing, Planning and Material Control, etc.
Assesses product conformance to engineering drawings, MP's, SP's, and to evaluate product quality via inspection.
Identifies non-conforming materials and documents, investigates, labels, segregates, repairs and resolves issues.
Audits the product to determine the effectiveness of operator inspections and also to assess compliance to standards and requirements. This audit will verify product conformance to customer need.
Validates transformer mechanical and electrical components, as well as assembly of same. Verifies insulation levels, electrical clearances, weld and paint quality, and cleanliness of product and process.
Works with Purchasing, Engineering, Manufacturing and the supplier to communicate requirements, verify processes, and identify opportunities for product improvement. Supplier visits will be a routine part of this responsibility.
Helps train new employees or retrain employees found deficient during inspection activities.
Gathers data and performs analysis to determine the root cause of problems identified through, non-conformance tracking, FDR's, audits and assessments will be a high impact responsibility of the Specialist. Helps eliminate and prevent problems.
Primary focus will be supporting the manufacturing process.
KNOWLEDGE, SKILLS & ABILITIES
Broad base of knowledge and effective skills of product and process knowledge, problem identification and analysis and writing and reporting skills.
Computer literacy with good PC skills and abilities to use Microsoft Word. Excel Outlook and PowerPoint.
Effective training skills, quality management skills, leadership and influencing skills.
EDUCATION AND EXPERIENCE
Required Education / Experience
Associates degree in an engineering related field or equivalent experience
3-5 years of related experience in transformer technical process work (skilled manufacturing/engineering)
Preferred Education / Experience:
ASQC certification
ADDITIONAL INFORMATION
Key Working Relationships
Functional Leaders: Engineering, Human Resources, Sales Operations, Sourcing. Works with hourly direct labor employees, support staff and suppliers on a routine basis, and might have occasional contact with customers
Physical Demands
Must be able to stand for extended periods of time
Working Conditions
Office environment and external customer sites
Prolec-GE Waukesha, Inc. is an equal opportunity employer and makes employment decisions without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, genetic information, disability, protected veteran status, or any other reason prohibited by applicable law.
$50k-85k yearly est. Auto-Apply 32d ago
Quality Assurance Specialist
Actalent
Quality assurance specialist job in Rocky Mount, NC
Job Title: Quality AssuranceSpecialist IJob Description The Quality Assurance (QA) Specialist I is responsible for ensuring that all products manufactured meet the highest quality standards. This role requires a fundamental knowledge of the principles and concepts of cGMPs in pharmaceutical manufacturing and site production processes. The position ensures adherence to regulatory expectations and GxP. The QA Specialist I will oversee manufacturing processes, including formulation, equipment and commodity preparation, aseptic services, and warehouse processes. Collaboration with cross-functional business groups and management is essential.
Responsibilities
* Perform real-time batch record reviews on the production floor to prevent deviations and facilitate real-time corrections.
* Conduct full reviews post-manufacturing and manage corrections to remediate deviations prior to product release.
* Complete periodic checks of auxiliary manufacturing documentation such as production logbooks, forms, and tickets.
* Perform daily and weekly walkthroughs of production and warehouse areas, escalate identified observations, and track the closure of action items.
* Participate in Method 1 meetings to provide quality oversight and support in identifying true root causes and associated CAPAs for manufacturing deviations.
* Utilize systems related to QA activities, including eQMS, Trackwise, RDOCS, and Batch Tracker.
* Use SAP for placing and removing product holds.
* Support on-site regulatory inspections and internal audits, including serving as an audit scribe and preparing pre-audit activities.
* Support Continuous Improvement initiatives to enhance safety and processes and successfully utilize IMEx tools.
Essential Skills
* Strong reading comprehension.
* 1-2+ years of GMP experience required.
* Understanding of batch records and key elements, including ALCOA principles and Data Integrity concepts.
Additional Skills & Qualifications
* Experience with operations documentation or direct batch record experience.
* Exposure to shop floor quality processes.
Work Environment
This position requires on-site work in containment areas with scrub protocols in place. The work schedule is from 4:30/5:00 PM, Monday through Friday.
Job Type & Location
This is a Contract to Hire position based out of Rocky Mount, NC.
Pay and Benefits
The pay range for this position is $30.00 - $40.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Rocky Mount,NC.
Application Deadline
This position is anticipated to close on Jan 28, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$30-40 hourly 4d ago
Document Specialist I, Mail Center
Resurgent Capital Services 4.4
Quality assurance specialist job in Greenville, NC
About Us Fueled by a fundamental belief in innovation, Resurgent Capital Services is an industry-leading financial services company in our sector. It all began 25 years ago when a small group of successful entrepreneurs had a vision for a new type of asset receivables company. One with a commitment to superior service and a personal touch with every interaction. We believe that demonstrating integrity in everything we do, maintaining a strong commitment to compliance, and doing things the right way is a sustainable business model. We want you to feel like your work has an impact and makes a difference every day. Join us as we develop strategies for change and transform the trajectory of your career!
Notice for California Residents - California Privacy Policy
Summary:
The Mail Center Document Specialist I uses their process knowledge to perform scanning of incoming documents and checks, as well as performing other mail/file services, such as mail pick up, loan mod entry, electronic customer service sort, indexing documents, and pulling/shelving files. This position reports to the Mail Center Supervisor.
Roles & Responsibilities:
* Execute various scanning processes
* Execute outgoing USPS Mail process
* Execute affidavits process
* Execute customer service electronic sort process
* Execute various indexing processes
* Audit work for completeness prior to scanning and indexing
* Responsible for the pick-up delivery of all mail, small packages and scan requests from each floor at the designated mail cabinet locations
* Replace Iron Mountain signage on shred bins and ensure each bin is secured with a lock
* File/Shelve documents
Skills & Qualifications:
* Some experience preferred, but not required
* Ability to work in a detail oriented, time sensitive environment
* Strong time management skills
* Ability to prioritize workload to meet deadlines and achieve volume goals and performance standards
* Ability to handle confidential materials in a professional and ethical manner
* Excellent communication and interpersonal skills and ability to communicate effectively at all levels in person, by phone, and by email
* Exhibit excellence in customer service and the ability to serve others by providing immediate attention to customers entering the DRCM
* Ability to review documents for long periods of time and recognize errors
* Basic computer skills with the ability to navigate efficiently
Educational Requirements:
* High School Diploma or GED required
* Four-year college degree preferred
Resurgent is an Equal Opportunity employer that is fueled by our diverse and inclusive work environment. Are you excited about this opportunity, but your skills and experience aren't an exact match? We encourage you to apply anyway! You may be just the person we are searching for to fill this or another position. We would love to consider you for the Resurgent team!
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws.
$37k-57k yearly est. Auto-Apply 14d ago
Senior Quality Specialist
BASF 4.6
Quality assurance specialist job in Greenville, NC
Now hiring! Senior Quality SpecialistGreenville, OH - Onsite - Domestic Relocation Availalable - We are looking for a Senior Quality Specialist to join our team in Greenville, OH. Come create chemistry with us! At BASF, we create chemistry through the power of connected minds. By balancing economic success with environmental protection and social responsibility, we are building a more sustainable future through chemistry. As the world's leading chemical company, we help our customers in nearly every industry meet the current and future needs of society through science and innovation. The Senior Quality Specialist plays a critical role in ensuring that products, processes, and services consistently meet both internal and external quality standards. This position is instrumental in maintaining compliance with global frameworks such as IATF 16949, ISO 9001, VDA 6.3, and internal O&M requirements. You will champion Six Sigma continuous improvement initiatives to eliminate process inefficiencies and waste as well as share expertise through coaching and training team members to build quality awareness and capability. Provides expertise in disciplined methodologies for defining, measuring, analyzing, improving and controlling the quality in every one of the company's products, processes and transactions--with the goal of eliminating defects, improving efficiency and reducing costs. These improvements are strategically critical in that they allow the company to continue to provide the goods and services required by our customers while operating in the lowest possible cost structure. As a Senior Quality Specialist, you create chemistry by... Key Duties: * Provide expertise in disciplined methodologies for defining, measuring, analyzing, improving and controlling the quality in the company's products, processes and transactions--with the goal of eliminating defects, improving efficiency and reducing costs. (These improvements are strategically critical in that they allow the company to continue to provide the goods and services required by our customers while operating in the lowest possible cost structure).Key * DutiesLeading root cause investigations for non-conformances and implementing effective corrective and preventive actions (CAPA). * Optimizing quality systems and ensuring alignment with global standards. * Driving continuous improvement initiatives using Six Sigma methodology to eliminate process waste. * Coaching and training associates to build organizational quality capability. Core Competencies & Tools * Bulk Material & Manufacturing Process Expertise * Automotive Core Tools (APQP, PPAP, FMEA, MSA, SPC) * Data Analysis & Statistics for quality performance monitoring * SAP QM Module (with focus on Non-Conformance Management) * MinTab proficiency * Ability to present to leadership and problem solve * Office Suite & Dashboarding (Power BI and similar tools) If you have the following experience... * Solid data analytics and statistical background required - preferably in automotive industry *
IATF and MiniTab required * Degree in Engineering, Analytics, Chemistry or related field * Strong Project Management Skills * Lean/Six Sigma/Kaizen training & implementation experience * Good communication, presentation, coaching, teaching, and interpersonal skills * Comfortable working with all levels of management & staff * History of successfully implemented Six Sigma Projects, Lean Manufacturing, IATF internal and external audits, Core Tolls, CSR, etc. * Minimum 3 years' experience working as a Black Belt Create your own chemistry with you@BASF At BASF, you will have the chance to do meaningful work towards building a more sustainable future. In addition to competitive compensation and benefits, BASF provides you with access to a wide range of elements to help you be your best. It's what we call you@BASF. We are committed to providing benefits, programs, and opportunities that support our employees' overall well-being, personal growth, and a safe, collaborative, and inclusive work environment. Just some of the many benefits we offer include: * Flexible work arrangements whenever possible * Highly competitive retirement savings plan with company match and investment options * Well-being programs that include comprehensive mental health support for you and your household family members * Family forming benefits (fertility, adoption and surrogacy reimbursement, maternity/parental leave, and more) * Back-up child and elder care with discount programs for families of all ages and stages * Mentoring and career development opportunities that allow you to share, learn, and thrive * Matching gifts program that allows you to deepen the impact of your contributions to qualified charities. * Employee crisis support for when the unexpected happens * Access to our BASF wine cellar, employee discounts, and much more! About us As one of the largest chemical companies in North America we have been finding solutions for your everyday needs and addressing the most complex economic, environmental, and sustainability challenges for more than 150 years! At BASF we empower our employees with the tools, guidance and opportunities they need to advance and succeed in work and life. Giving you the support you need to be your best and fulfill your personal ambitions is what helps us create chemistry. After all, our success is linked to yours. Whatever path you envision, BASF is a great place to build a rewarding, successful career. Belong to Something Bigger. #belongat BASF Privacy statement BASF takes security & data privacy very seriously. We will never request financial information of any kind via email, private text message or direct message on any social medial platform or job board. Furthermore, we will never send a candidate a check for equipment or request any type of payment during the job application process. If you have experienced any of the above, please contact ************* to report fraud. Equal employment opportunities We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, age, citizenship, color, religion, sex, marital status, national origin, disability status, gender identity or expression, protected veteran status, or any other characteristic protected by law. Applicants must be currently authorized to work in the United States on a full-time basis.
$85k-102k yearly est. 10d ago
Food Safety & QA Supervisor
Smithfieldfoods 4.2
Quality assurance specialist job in Wilson, NC
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub.
A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now!
THE VALUE YOU'LL BRING:
The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section.
As part of our Food Safety & Quality Assurance team, you will ensure our products meet the highest safety and quality standards. You will conduct sanitation checks, enforce HAACP and USDA regulations, and track products from start to finish, implementing corrective actions as needed.
Overseeing FSQA programs in specific production areas, you will ensure compliance, train employees, and drive continuous improvement. With opportunities to step into FSQA Manager duties, you will play a vital role in delivering safe, high-quality products under brands like Smithfield, Eckrich, and Nathan's Famous.
If you are passionate about food safety, quality and leadership, join us and make an impact!
WHAT YOU'LL DO:
The below statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.
Food Safety & Quality Assurance Leadership - You'll ensure that all Food Safety, Quality Assurance, SQF, and Regulatory programs are executed and documented accurately, maintaining compliance and product integrity. Your role will involve investigating and resolving product/process failures quickly, minimizing downtime, and ensuring safety and quality standards are consistently met. You will collaborate closely with plant management, production teams, and the USDA to drive continuous improvement in food safety, quality, and sanitation.
Continuous Improvement & Compliance- You'll prevent failures by actively managing HACCP, SSOP, and product specifications. Leading efforts to improve product quality and processes in partnership with FSQA staff and Operations will be a key responsibility. Additionally, you will oversee and participate in plant committees and task forces, such as the Health and Safety Committee, to enhance safety and quality standards.
Sanitation & SQF System Ownership - You will conduct operational and pre-operational sanitation inspections and micro sampling to ensure the effectiveness of sanitation practices. As the owner of the SQF system, you'll maintain and reassess the SQF Plan regularly, ensuring it remains compliant and up to date. You will also communicate key updates and ensure team-wide awareness for the effective implementation of the SQF system.
Team Development - You'll manage the work assignments, training, and development of food safety and quality assurance staff, fostering a high-performance team that upholds the highest standards of food safety and quality.
WHAT WE'RE SEEKING:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.
Bachelor's degree from an accredited four-year college or university and 2+ years' relevant experience in food safety or quality assurance; or equivalent combination of education and experience.
Experience acting as a lead by providing training, coaching or mentoring to less experienced staff or through managing a process or project.
Familiarity with meat processing, USDA, HACCP, SSOP, and SQF
Ability to uphold regulatory, company, and customer standards and address inquiries or complaints.
OTHER SKILLS THAT MAKE YOU STAND OUT:
HACCP and SQF certifications preferred.
Ability to uphold regulatory, company, and customer standards and address inquiries or complaints.
Proficiency in database, inventory, manufacturing software, QMS systems, SAP, and MS Office.
Strong written and oral communication, with excellent decision-making and problem-solving abilities.
Strong planning, multitasking, and project management skills.
Must complete forms in English; ability to travel up to 20% and work extended hours or weekends as needed.
Ability to work effectively in a fast-paced environment, fostering positive relationships and a team-oriented atmosphere.
PHYSICAL DEMANDS & WORK ENVIRONMENT:
The physical demands described here are representative of those an employee should possess to successfully perform the essential functions of this job. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Office and plant setting. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals.
Occasionally lift and/or move up to 50 pounds
Specific vision includes close vision, distance vision, and ability to adjust focus. Additionally ability to differentiate colors.
Frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear.
Noise level in the work environment is usually moderate but can be loud when in the production area.
IndSPR-Ops
Relocation Package Available Yes
EEO Information
Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law.
If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at ************.
$64k-81k yearly est. Auto-Apply 7d ago
Quality Compliance Documentation Specialist
Bausch & Lomb 4.7
Quality assurance specialist job in Greenville, NC
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world-from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Purpose of Job:
The Documentation Specialist is responsible for processing all Greenville documents and for the oversight and management of the document control program.
This position is the site administrator for the document management electronic system (D2-GDMS) and ensures content of site documents meet regulatory and QMS requirements.
This position is also responsible for the records management process and coordinates the document retention and destruction process. The QA Documentation Analyst is the site document management and records management representative on global initiatives.
This position will also routinely provide administrative support for External audits (FDA, ISO, Global, etc.) when needed.
Key Activities:
* Process Greenville documents in GDMS to include reviewing, routing, promotion of effective documents, copying and distributing copies.
* Maintain the Annual SOP Review Process, which includes sending monthly notifications of SOPs to be reviewed, issuing periodic SOP status reminders and completing monthly reports.
* Manages process for review of global document updates to ensure local changes are made as necessary to maintain compliance with the global Quality Management System.
* Provide administrative support for external audits and as needed for the Quality Systems group.
* Coordinates the record retention and destruction process.
* Site administrator for electronic document management system.
* Reviews document content and edits as necessary to ensure compliance.
* Additional activities to support Quality System Compliance Department as needed.
Qualifications:
Education:
Minimum AS degree required and BS degree is preferred. Equivalent experience may be recognized.
Experience:
* Minimum of 3 years of prior office and/or computer (Microsoft Office) experience required.
* Minimum of 2 years experience in a GMP regulated environment is required.
Preferred Skills:
* Well organized with the ability to multi-task and shift priorities as needed to meet customer demands.
* Demonstrated proficiency in Microsoft Office to include use of Excel spreadsheets, Microsoft Word, and ACCESS database. Knowledge and experience with an electronic document management system.
Demonstrated proficiency in document authoring with preferred experience in technical writing.
This position may be available in the following location(s): US - Greenville, SC (Plant)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement.
Our Benefit Programs: Employee Benefits: Bausch + Lomb
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
$37k-47k yearly est. 60d+ ago
Quality Specialist (Regulated Industry)
Mentor Technical Group 4.7
Quality assurance specialist job in Wilson, NC
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Performs all functions listed below with direct supervision.
Support to issue and solve internal corrective measures report.
Ensure current service/product quality specification fulfill client's requirements.
Support Quality Management Systems operation within organization.
Provide support for design, execution and maintenance of quality system processes at respective departments.
Help department to coordinate training to operating procedure changes or new system implementation.
Ensure operating procedures are of use to end users.
Direct writing and review operating procedures (OP's) to ensure compliance, efficiency and clarity.
Participate in corrective action discussions as necessary.
Revise department complaints and implement corrective actions for clarity and fullness in investigations.
Comply all activities with MTG's policies as well as departmental procedures to reduce risk and losses.
Ensure program activities are in compliance with applicable government regulations and company quality assurance standards.
Recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance department effectiveness.
Support the Quality Manager in Client Internal Audits.
Comply with the ISO Certifications ISO 9001 and ISO 17025.
Prepare evaluation reports and submit them to Quality & Customer Service Manager.
Function as an information source for bottlers and other departments when critical quality issues arise.
Establish and manage professional customer rapport to drive solutions to attain business needs.
Other responsibilities as assigned by supervisor/management.
Educational or Equivalent Requirements:
Degree in Engineering, Science, or related curriculum
Bachelor's Degree preferred
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
$82k-109k yearly est. Auto-Apply 19d ago
Senior QA Specialist, Compliance
J&J Family of Companies 4.7
Quality assurance specialist job in Wilson, NC
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
Professional
**All Job Posting Locations:**
Wilson, North Carolina, United States of America
**:**
The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina.
The QA Specialist reports to the Senior Manager, Quality Assurance.
**Essential Job Duties and Responsibilities**
**QA Specialist, Compliance**
This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities:
+ Responsible for execution of Risk Management Program through the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues.
+ Implement and execute the Notification to Management/Escalation procedures as defined by J&J standards and procedures. Facilitate timely resolution through coordination with relevant department and teams.
+ Responsible for development and implementation of Data Integrity Program for the BioNC site in alignment with J&J standards and procedures.
+ Responsible for preparation, review and submission of data reported to Health Authorities including BPDRs, Inspection responses and review of Regulatory submission documents.
+ Collaborates and contributes to Site Inspection Readiness Activities, including global internal audits and assessments.
+ Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
+ Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance.
**Additional Job Duties and Responsibilities:**
+ Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
+ Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
+ Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
+ Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
+ Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
**Minimum Qualification**
+ Bachelor's degree in a scientific or engineering discipline is required.
+ Minimum six (6) years experience working within the biological and/or pharmaceutical industry in a quality, manufacturing, or compliance role.
+ Strong knowledge of relevant regulations and quality management principles, such as Good Manufacturing Practices (GMP), ICH, and ISO standards.
+ Understanding and experience in application of global regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment.
+ Experience with regulatory inspections and response to observations. (QA Specialist, Compliance)
+ Proficiency in risk management methodologies such as FMEA.
**Key Competencies - Other requirements**
+ An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
+ Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
+ Proven ability to manage multiple priorities and work independently with minimal supervision.
+ Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
+ Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
+ Ability to build and nurture strong and positive relationships. The ability to work in a team environment and interact with all levels of the organization.
**Required Skills:**
**Preferred Skills:**
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
**The anticipated base pay range for this position is :**
$94,000.00 - $151,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
$94k-151.8k yearly 7d ago
Supervisor, QA - Batch Release
Invitrogen Holdings
Quality assurance specialist job in Greenville, NC
The Quality Assurance (QA) Supervisor, Batch Release oversees QA activities and programs such as auditing, record review, final product functions, document management, complaints, oversight of quality systems, and investigations within QA. This role provides leadership to assigned staff, ensuring compliance with regulatory requirements and maintaining high standards of quality.
Key Responsibilities:
Champion Quality Culture: Aid personnel in understanding the application of policies and controls to promote a quality-focused culture.
Leadership and Empowerment: Lead organizational change, empower staff, and cultivate relationships to build effective teams.
Engagement and Motivation: Drive engagement and create a motivating climate to support staff in achieving personal career goals while meeting organizational goals.
Supervision: Supervise staff performing quality and manufacturing audits, record review, final product release functions, complaints, APR, validation, and investigations.
Quality Assurance: Ensure the quality of methods, processes, materials, and products through coordination and review of operations, staff training, and system/process improvements.
Technical Expertise: Provide technical expertise for systems and new product introduction.
Regulatory Compliance: Assure compliance with all applicable regulations by interpreting regulatory requirements and maintaining systems.
Resource Management: Lead resources by budgeting and ensuring staff availability to meet business needs. Participate in budget planning and cost-saving projects.
Performance Management: Ensure staff have performance plans with metrics in place, conduct performance reviews twice a year, and identify and handle performance/field issues.
Training and Development: Provide training and career development opportunities for staff.
Risk Assessment: Conduct risk assessments and take appropriate actions to ensure adequate controls for product quality, safety, and business risks.
Qualifications:
Bachelor's degree required, preferably in a scientific related field.
5+ years of experience in a cGMP manufacturing or QA Operations environment with strong knowledge of GMP operations and regulations.
2+ years prior experience in manufacturing operations, preferably in pharmaceutical, food, or cosmetic industry.
2+ years supervisory/leadership experience required.
Equivalent combinations of education, training, and relevant work experience may be considered.
Proficient in cGMPs applicability and decision making.
Familiarity with SAP, TrackWise, Electronic Document Management System (eDMS), and Laboratory Information Management Systems (LIMS) is an advantage.
Familiarity with concepts, practices, and procedures related to Batch Release activities.
Ability to manage and lead professional staff to achieve goals and resolve complex technical problems.
Strong organizational skills and attention to detail.
Self-starter, mature, independent, and dependable.
Ability to work in a fast-paced environment under pressure and multi-task.
High degree of confidentiality and discretion.
Effective time management and prioritization skills.
Excellent interpersonal skills to establish and maintain effective working relationships.
Highly effective verbal and written communication skills.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.
What We Offer
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Compensation
Competitive Pay
Annual performance-based bonus
Annual merit performance-based increase
Excellent Benefits
Benefits & Total Rewards | Thermo Fisher Scientific
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
401K
Tuition Reimbursement
Employee Referral Bonus
Career Advancement Opportunities
OTHER
Relocation assistance is NOT provided
Must be legally authorized to work in the United States if now or in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening
$48k-77k yearly est. Auto-Apply 47d ago
Quality Systems Manager
Grifols Sa 4.2
Quality assurance specialist job in Greenville, NC
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Quality Systems Manager (QSM) PRIMARY RESPONSIBILITIES: * Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. * Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties. * Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. * Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files. * Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained. * Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks. * Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required. * Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations. * Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product. * Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. * Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation and authorizes final shipment. * Performs a review of the documentation of unsuitable test results and unit lookback information. * Performs a review of donor adverse event reports and the applicable related documentation. * Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file. * Performs employee training observations to ensure staff competency prior to releasing employees to work independently. * Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance. * Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities. * Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues * Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented. * Holds monthly Quality Meeting to communicate status updates and manage action outcomes. JOB REQUIREMENTS: * Bachelor of Science degree or equivalent. *
Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master's degree with 2 years of experience. * Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood preferred. KNOWLEDGE, SKILLS, AND ABILITIES: Command of interpersonal communication, organizational and problem-solving abilities. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance. Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. Ability to travel when needed for meetings, events, and occasional support of other centers. Occupational Demands Form # 6: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32 degrees F, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. BENEFITS: We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! #biomatusa Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Greenville:USGRN - GreenvilleNC-Memorial Dr-GBPC
$55k-86k yearly est. 57d ago
Sr. Quality Specialist
Integrated Resources 4.5
Quality assurance specialist job in Rocky Mount, NC
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Title: Sr. Quality Specialist
Location: Rocky Mount - NC
Duration: 18 Months
Job Description:
The Sr. Quality Specialist shall independently conduct and write complex formal investigation reports with input from area SMEs.
The candidate will function as an independent reviewer of drafted investigations providing constructive feedback and in some instances act as a coach to the investigator.
This position will also perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
The incumbent will assist in the tracking and trending of corrective and preventative action to assure timely closure.
This person will also perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.
Position Responsibilities
In order of importance, list the primary responsibilities critical to the performance of the position.
Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.
2-5 years' experience in pharmaceutical quality environment required
Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products.
Working knowledge of environmental monitoring and aseptic manufacturing.
Understanding of process validation requirements.
American Society for Quality (ASQ) certification is an asset.
Pharmaceutical operations experience and/or knowledge.
Experience in a solutions facility preferred.
Working knowledge of FDA regulations.
Knowledge of various quality tools such as root cause analysis, DMAIC process, fishbone analysis, etc.
Prior investigation writing experience (with determination of product impact).
Strong oral and written communication presentation, interpersonal skills and adept at communication with employees at all levels within the organization.
Excellent facilitation skills and ability to facilitate strategy meetings.
Superior technical writing and problem solving skills.
Organize data, extract key information and write technical summary reports.
Expertise with word-processing, spreadsheet, and presentation software.
TrackWise experience a plus.
Qualifications
Education and Experience
Indicate the formal education, certification or license(s) required and/or preferred.
Include the minimum number of years of relevant experience required for the position (where legally permissible).
Bachelor's degree (science preferred) with 3-5 years' experience in the FDA regulated industry.
Additional Information
Kind Regards,
Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$73k-95k yearly est. 60d+ ago
Quality Systems Manager
Biomat USA, Inc. 4.2
Quality assurance specialist job in Greenville, NC
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Quality Systems Manager (QSM)**
**PRIMARY RESPONSIBILITIES** :
· Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center.
· Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
· Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
· Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files.
· Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
· Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
· Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
· Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
· Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
· Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
· Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation and authorizes final shipment.
· Performs a review of the documentation of unsuitable test results and unit lookback information.
· Performs a review of donor adverse event reports and the applicable related documentation.
· Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
· Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
· Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
· Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
· Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
· Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
· Holds monthly Quality Meeting to communicate status updates and manage action outcomes.
**JOB REQUIREMENTS** :
· Bachelor of Science degree or equivalent.
+ Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master's degree with 2 years of experience.
· Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood preferred.
**KNOWLEDGE, SKILLS, AND ABILITIES** :
Command of interpersonal communication, organizational and problem-solving abilities. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance. Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. Ability to travel when needed for meetings, events, and occasional support of other centers.
Occupational Demands Form # 6: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32 degrees F, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Ability to apply abstract principles to solve complex conceptual issues.
**BENEFITS:**
**We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us!**
\#biomatusa
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
**Location: NORTH AMERICA : USA : NC-Greenville:USGRN - GreenvilleNC-Memorial Dr-GBPC**
Learn more about Grifols (**************************************
**Req ID:** 537316
**Type:** Regular Full-Time
**Job Category:** GENERAL MANAGEMENT
$53k-79k yearly est. 56d ago
Quality Control Specialist
Revvity
Quality assurance specialist job in Greenville, NC
Job TitleQuality Control Specialist
About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.
Find your future at Revvity
DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS:
Responsible for Document Control and Records Retention.
Trends data from Quality System inputs and creates monthly charts and reports.
Assists in Quality Management Review preparation.
Assists with Failure Investigations (Complaint, Non-Conformance, Supplier, etc.)
Participates in internal audit program.
Works with Quality and Operations management on short and long term quality planning and quality system improvements initiatives.
Drafting new, and revising existing Standard Operating Procedures (SOP)
Approval to ship conforming product following full review of process documentation.
Make records of quality activities per specified procedures.
Maintain all required documentation of work performed and ensure that all forms and materials are labeled properly.
BASIC QUALIFICATIONS:
BS/BA Degree in a scientific/technical field and 2+ years working in a regulated environment.
OR
AS Degree in a scientific/technical field and 4+ years working in a regulated environment.
PERFERRED QUALIFICATIONS:
ASQ Certifications a plus.
Working with Pharma or Medical Devices preferred
Experience with ISO 13485 or ISO9001 preferred.
Demonstrated ability to work effectively and positively with all levels of an organization.
Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
Strong organization skills required.
WORK ENVIRONMENT:
Temperature controlled office and manufacturing environment with large printing and related equipment.
PHYSICAL REQUIREMENTS:
Sitting, standing, walking, stooping, bending, squatting, leaning, climbing stairs and ability to lift 40 pounds.
COMPENSATION RANGE:
The annual base salary range for this full-time position is $55,000-70,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.
#LI-CH1
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
Medical, Dental, and Vision Insurance Options
Life and Disability Insurance
Paid Time-Off
Parental Benefits
Compassionate Care Leave
401k with Company Match
Employee Stock Purchase Plan
Learn more about Revvity's benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.
*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability-or unable to use-the online application system and need an alternative method for applying, you may contact ********************.
$55k-70k yearly Auto-Apply 2d ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Greenville, NC?
The average quality assurance specialist in Greenville, NC earns between $41,000 and $111,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.
Average quality assurance specialist salary in Greenville, NC
$67,000
What are the biggest employers of Quality Assurance Specialists in Greenville, NC?
The biggest employers of Quality Assurance Specialists in Greenville, NC are: