Specialist 2, Quality Assurance
Quality assurance manager job in Lititz, PA
The Quality Specialist II will be accountable to support Product Review reports and to support investigations pertaining to observations or trends discovered during data collection. The Quality Specialist II will also be accountable for supporting Laboratory Information Management System (LIMS) Master Data changes needed by the Quality Control Laboratory.
Responsibilities:
Communicate to Quality Management the observations or trends discovered during the data collection and review of the Product Reviews. Maintain metrics and support management reviews and other presentations.
Performs other duties, as assigned.
Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills and the ability to work independently without supervision is required
Ability to work effectively on cross functional teams is required.
Experience:
Support Product Review completion per scheduled timeline and store in document management system.
Fulfill LIMS Master Data requests.
Review Master Data submissions for accuracy and provide feedback as necessary
Skills:
Excel, LIMS, Word
Medium, must be able filter and sort spreadsheets
ASQ Certification welcome
Education:
Bachelors
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Azhar
Email: ****************************
Internal Id: 25-54038
Specialist 2, Quality Assurance
Quality assurance manager job in Lititz, PA
Immediate need for a talented Specialist 2, Quality Assurance. This is a 14+months contract opportunity with long-term potential and is located in Lititz, PA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:25-93990
Pay Range: $25 - $30/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Communicate to Quality Management the observations or trends discovered during the data collection and review of the Product Reviews.
Maintain metrics and support management reviews and other presentations.
Support Product Review completion per the scheduled timeline and store in the document management system.
Fulfill LIMS Master Data requests.
Review Master Data submissions for accuracy and provide feedback as necessary.
Performs other duties, as assigned .
Key Requirements and Technology Experience:
Key Skills; Quality Assurance/QA
Laboratory Information Management System/LIMS
Product Review/Investigation
Master Data
Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills, and the ability to work independently without supervision is required.
Ability to work effectively on cross-functional teams is required.
BA degree is required.
Excel, LIMS, Word .
Medium, must be able to filter and sort spreadsheets.
ASQ Certification welcome.
Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.
Food Safety and Quality Manager
Quality assurance manager job in Womelsdorf, PA
Employee Type:
Full time
Job Type:
Quality
Job Posting Title:
Food Safety and Quality Manager
About Us:
TreeHouse Foods (NYSE: THS) is a leading manufacturer of private label packaged foods and beverages, operating a network of over 20 production facilities and several corporate offices across the United States and Canada. At TreeHouse Foods, our commitment to excellence extends beyond our products and revolves around our people. We are investing in talent and creating a performance-based culture where employees can do their best work and develop their careers, directly impacting our mission to make high quality, affordable food for our customers, communities, and families. We hope you will consider joining the team and being part of our future.
Named one of America's Best Large Employers by Forbes Magazine, we are proud to live by a strong set of values and strive to "Engage and Delight - One Customer at a Time." Guided by our values-Own It, Commit to Excellence, Be Agile, Speak Up, and Better Together. We are a diverse team driven by integrity, accountability, and a commitment to exceptional results. We embrace change, prioritize continuous learning, and foster collaboration, transparency, and healthy debate. Together, we set each other up for success to achieve enterprise-wide goals.
What You Gain:
Competitive compensation and benefits program with no waiting period - you're eligible from your first day!
401(k) program with 5% employer match and 100% vesting as soon as you enroll.
Comprehensive paid time off opportunities, including immediate access to four weeks of vacation, five sick days, parental leave and 11 company holidays (including two floating holidays).
Leaders who are invested in supporting your accelerated career growth, plus paid training, tuition reimbursement and a robust educational platform - DevelopU - with more than 10,000 free courses to support you along the way.
An inclusive working environment where you can build meaningful work relationships with a diverse group of professionals. Take advantage of opportunities to build on our team-oriented culture, such as joining one of our Employee Resource Groups.
Access to our wellness and employee assistance programs.
Job Description:
About the Role:
As the site Food Safety and Quality Manager, you will oversee and ensure the implementation of Quality Assurance (QA) programs for the Womelsdorf, PA site, a manufacturer of confections. This role upholds product quality, food safety, and sanitation in compliance with company standards and regulatory requirements.
You'll add value to this role by performing various functions including, but not limited to:
Oversee, implement, and maintain QA programs, including Formula Control, Allergen Control, Non-Conforming Products, Recalls, Food Safety Plans, and pest control systems.
Develop, implement, and manage comprehensive sanitation programs for daily and periodic cleaning of the facility.
Define and enforce best laboratory practices and quality policies.
Ensure compliance with company, state, and federal sanitation regulations.
Collaborate with R&D to improve product quality and cost-effectiveness, support product changes, and oversee plant testing.
Coach, mentor, and develop quality and sanitation leaders/supervisors in addition to providing quality and food safety training for employees at all levels.
Conduct quality and sanitation audits and summarize technical data to identify trends and corrective actions as well as, support quality systems and initiatives.
Serve as the plant's liaison for regulatory authorities, including USDA, FDA, and third-party auditors.
Important Details:
This is a full-time, on-site role on our first shift. Occasional flexibility is required to support alternate shifts.
You'll fit right in if you have:
Bachelor's degree in food science, Biology, or a related field. SQF Practitioner certification and Food Defense Program leadership experience preferred.
Minimum of 5 years of supervisory experience in a food manufacturing environment.
In-depth knowledge of sanitation practices, GMPs, FDA/USDA regulations, and third-party audits.
Hands-on experience with GFSI certification, CFR expectations, pre-operational inspections, and SPC systems.
Demonstrated problem solving, leadership, and analytical skills.
Experience in creating, executing, and monitoring manufacturing technical standards and procedures.
Experience using Microsoft Office.
Your TreeHouse Foods Career is Just a Click Away!
Click on the “Apply” button or go directly to ****************************** to let us know you're ready to join our team!
At TreeHouse Foods, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work to help us “Engage and Delight - One Customer at a Time”. TreeHouse Foods is an Equal Opportunity Employer that prohibits discrimination or harassment of any type. All qualified applicants are considered for employment without regard to race, color, national origin, age, sex, sexual orientation, gender, gender identity or expression, disability status, protected veteran status, or any other characteristic protected by law. Applicants who require an accommodation to participate in the job application or hiring process should contact disability-accommodations@treehousefoods.com
TreeHouse Use Only: #IND1
Auto-ApplyDirector of Quality
Quality assurance manager job in Lancaster, PA
Director of Quality - Remote (Lancaster, PA Region) Industry: Printed Circuit Board (PCB) Manufacturing Are you ready to lead quality excellence in PCB manufacturing? Our client is seeking a Director of Quality to shape their quality strategy, drive continuous improvement, and uphold their reputation for precision and reliability. This is a unique succession opportunity-you'll work side-by-side with their current Director of Quality, an industry veteran, gaining hands-on mentorship and decades of expertise before stepping fully into this key leadership role.
What You'll Do
Lead strategic quality initiatives, ensuring product excellence and customer satisfaction.
Act as the primary contact for customer and supplier quality concerns, driving timely resolutions.
Maintain and enhance ISO certification and compliance documentation.
Oversee supplier qualification and performance metrics, ensuring adherence to industry standards.
Develop and improve quality policies, processes, and corrective action systems.
Collaborate across departments to promote proactive quality improvement.
Represent in audits, customer reviews, and vendor evaluations.
What You'll Bring
5+ years in quality management or supplier quality within manufacturing (PCB experience strongly preferred).
Strong communication and leadership skills.
Proven track record in ISO compliance, corrective action systems, and continuous improvement.
Experience analyzing supplier performance data and implementing process enhancements.
Technical proficiency in interpreting drawings, Gerber files, and quality specifications.
Hands-on understanding of manufacturing processes, inspection techniques, and quality documentation.
Associate's or Bachelor's degree in engineering, manufacturing, or quality.
Apply Today
Email your resume to Joe Saunders at *************************.
Easy ApplyQuality Manager | Foods
Quality assurance manager job in Reading, PA
Title: Quality Manager - Food Manufacturing Overview:Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.
Hire Type: Direct HireBenefits: Medical Dental VisionBonus/ Incentives/ Stock Options: 401k matching Pay: $100-115k
Job Summary:
We are seeking an experienced Quality Manager to lead plant-wide food safety and quality initiatives at a high-volume food manufacturing facility. This role is responsible for guiding the Quality team, maintaining regulatory compliance, and driving continuous improvement efforts. The ideal candidate is an organized, hands-on leader who is confident in decision-making, cross-functional coordination, and fostering a strong culture of food safety on the production floor.
Job Duties:
Oversee daily quality and food safety operations in alignment with company standards and regulatory requirements.
Maintain audit readiness and ensure compliance with USDA, FDA, FSMA, and customer expectations.
Lead investigations into quality deviations; identify root causes and implement corrective and preventive actions.
Manage hold and release programs, sanitation oversight, pest control, environmental monitoring, and laboratory testing activities.
Review, update, and maintain Quality Management System documentation, work instructions, and SSOPs.
Partner closely with Operations, Maintenance, and R&D to ensure processes, product specifications, and preventive maintenance programs support food safety and product quality.
Serve as the primary contact for customer quality inquiries and complaint resolution.
Track, analyze, and report quality KPIs to plant and corporate leadership.
Provide training, coaching, and leadership development to plant personnel related to food safety and compliance.
Contribute to capital project planning and annual budget activities.
Qualifications:
Bachelor's degree in Food Science, Biology, Microbiology, or related technical field (or equivalent experience).
5+ years of quality assurance experience in food, beverage, or related regulated manufacturing environment.
Previous supervisory or management experience required.
HACCP, SQF Practitioner, and/or PCQI certification preferred (or ability to obtain).
Strong understanding of cGMPs, environmental monitoring, sanitation, and lab practices.
Excellent communication, leadership, analytical, and cross-functional collaboration skills.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Director of Quality Assurance & Regulatory Affairs
Quality assurance manager job in Allentown, PA
Job Description
HoverTech International, a medical device company and leader in the safe patient and handling and movement is seeking a Director of Quality Assurance & Regulatory Affairs to join their team. This opportunity is in Allentown, PA, has one direct report and requires 10% international travel.
The Director of Quality Assurance & Regulatory Affairs will lead the company's quality system and regulatory compliance activities. This role is responsible for ensuring that the Quality Management System meets FDA, ISO 13485, and global regulatory requirements, while also serving as the company's primary regulatory contact for the U.S., Canada, U.K., and EU.
The ideal Director of Quality Assurance & Regulatory Affairs candidate has solid experience with Class II devices, understands global regulatory frameworks, and is comfortable in a hands-on leadership role in a growing organization.
HoverTech International offers…
Competitive compensation
100% employer paid benefits (for employee and family)
Medical, dental, vision
401K plan
Life insurance
Tuition reimbursement
Laid-back dress code and is dog friendly!
The Director of Quality Assurance & Regulatory Affairs will be responsible for:
Quality Assurance (QA)
Maintain and continually improve the Quality Management System in compliance with FDA 21 CFR 820, ISO 13485, and applicable global standards.
Oversee CAPA, complaint handling, non-conformances, internal audits, and supplier quality.
Serve as the Supplier Quality Contact, managing supplier evaluations, audits, and ongoing performance monitoring.
Lead document control, change control, training systems, and production quality processes.
Oversee risk management activities in accordance with ISO 14971.
Serve as the Management Representative during audits and inspections.
Regulatory Affairs (RA)
No 510(k) submissions required, but responsible for all ongoing global regulatory maintenance.
Serve as the company's: FDA Registration Owner and primary FDA contact, US Agent for applicable products, EU PRRC (Person Responsible for Regulatory Compliance) for EUDAMED, Canada Regulatory Contact (e.g., MDEL maintenance) and UK Responsible Person / PRRC.
Maintain device listings, establishment registrations, and regulatory documentation for all markets.
Coordinate with distributors, authorized representatives, and regulatory bodies.
Review and approve labeling, IFUs, marketing content, and product changes for regulatory compliance.
Monitor regulatory changes and communicate impacts to leadership.
Leadership
Work closely with Engineering, Operations, and Executive Leadership to embed quality and regulatory requirements across the organization.
Provide clear, practical regulatory guidance for sustaining products and new initiatives.
Represent QA/RA during leadership meetings, audits, and customer visits.
Director of Quality Assurance & Regulatory Affairs Qualifications:
Bachelor's degree in engineering, science, quality, regulatory, or related field.
5-10+ years of regulatory and quality experience in medical devices.
5+ year's experience with a QMS (Greenlight Guru preferred).
Strong understanding of Class I/ Class Il medical device requirements.
Experience with FDA QSR, ISO 13485, and global regulatory frameworks.
Experience managing establishment registrations and serving as a regulatory contact.
Background in supplier quality, audits, and QMS compliance.
Excellent organizational, documentation, and communication skills.
Must be open to 10% international travel.
Quality Manager
Quality assurance manager job in Reading, PA
Quality Manager - Reading, PA
Hours are 8:00am - 5:00pm Monday through Friday
Supervises and coordinates activities of workers engaged in inspecting production work to ensure that product quality meets customers' expectations. Assists the Director of Engineering and Quality in planning, coordinating and directing quality control programs. Employee may perform other related duties as required to meet the ongoing needs of the organization.
Essential Responsibilities:
To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ensures the capability of the Quality Assurance Department to meet inspection requirements. This responsibility includes specifying and requisitioning inspection tools, fixtures, and other equipment.
Dispositions nonconforming items and material by conferring with Sales, Materials, Production, Quality Manager and/or General Management.
Determines sampling plans where no customer specified requirements exist. Maintains engineering documentation files for use by manufacturing.
Obtains clarification from Sales/Engineering where critical information in ambiguous or missing.
Review new item documentation and determine inspection criteria.
Requisitions supplies and other consumables.
Ensures that the department complies with Company policies and procedures, including employee safety.
Directs set-ups for product inspection.
Recommends measures to improve inspection methods and productivity.
Maintains quality records per customer and internal requirements
Confers with other Supervisors to coordinate activities.
Contributes to the positive environment of the manufacturing team.
Ensure that all work procedures within the department are performed in accordance to the established Quality and Environmental Management Systems
Essential Skills:
One year certificate from college or technical school; 3-5 years of related experience and/or training; or equivalent combination of education and experience.
Experience in a leadership role. Ability to lead, coach and develop.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondences. Ability to speak effectively before groups of customers or employees of the organization.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plan and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, rations, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exits.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Brentwood offers professional growth potential, pleasant work environment, and an excellent wage and benefits package including 401K w/employer match. Brentwood Industries, Inc., provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.
At Brentwood, we have a passion for both our products and our people. Our goal as an employer is to help you excel as an individual and as part of a team by providing you with a satisfying, motivating and stimulating work experience. The varied nature of the environment at Brentwood allows you to work alongside industry professionals on a wide range of projects, contributing your knowledge and strengths to develop innovative, market-driven solutions.
To begin the application process, please complete all required fields below and click “Apply” to continue.
Please note: We are not working with external recruiters at this time and are not accepting unsolicited resumes.
Auto-ApplyClinical Quality Manager
Quality assurance manager job in Collegeville, PA
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
The correct title for this position is Clinical Quality Manager. Role Description The Clinical Quality Manager (CQM) is responsible for driving Asset and Study level quality management for specific assets primarily in the Alliance Partner (AP) model by maintaining 'quality' line-of-sight from Asset to Clinical Investigator Site level.
• With this focus, the CQM role brings deep knowledge for asset- and study-level quality across clinical trial business process areas. In partnership with the Dev Ops Asset Lead and BU Clinical Lead, the CQM will ensure study level quality oversight, manage relevant Asset and Study level quality issues, and will be instrumental in ensuring that Asset and Study level information is appropriately incorporated within the GCP QMS. Act as point person to stakeholders and asset teams for asset and study quality risk management and quality issues management.
• CQM may also continue to provide additional centralized services as described below as necessary. Responsibilities As CQMs are assigned to specific Asset, responsibility includes: Facilitate IQMP Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) Facilitate study-level quality risk management activities (including IQMP activity)
• Drive consistent implementation of IQMP across study-teams Facilitate IQMP development to ensure that study teams: Identify factors that are critical to quality and pre-specify appropriate quality metrics Identify high priority risks to quality and prospectively implement appropriate mitigation plans
• Facilitate IQMP implementation, via participation on the asset clinical operations team, by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner. Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CQM team Provide feedback to IQMP BPO to continuously improve IQMP approach Quality Gate and/or Quality Compliance Assessments Perform quality gate assessments (e.g. quality, completion or compliance assessment of key quality elements (e.g. prior to study start-up, during conduct phase, and study closeout)
• Perform asset or study-focused quality compliance assessments Track compliance or performance against expectations, and manage outcomes Asset Clinical Quality Management Facilitate study-level quality risk management activities (including IQMP activity) Maintain comprehensive portfolio of quality issues across Asset Provide quality management / operational expertise Review quality reports and metrics for asset/study implications and remediation needed; to identify useful knowledge to apply/share cross-functionally IQMP PSQRV visit information for trends across asset Significant deviations/qualifying quality issues (QQI) across asset
• Audit/Inspection Metrics Audit and/or CAPA Trend reports Protocol Deviations Metrics and Trends Guide asset/study team on appropriate quality remediation actions, facilitates remediations, and tracks/ensures completion in close collaboration with DevOps Asset Lead and BU Clinical Lead (e.g. remediation for pervasive cross-asset protocol deviation issues)
• Ensure timely progress and completion for quality activities for which study teams/Alliance Partner are responsible per Clinical Trial Process Quality Standards (CTPQS): (e.g. Audit CAPA completion, study level quality issue action tracking, inspection readiness) Participates on QQI teams to provide guidance on actions to address quality issues (e.g. issuance of Protocol Deviation Alert Letters (PDAL), or actions to address QQI) May attend governance meetings and provide knowledge/trend information as appropriate
• Perform Root Cause Analysis (RCA) for ad hoc asset quality issues Participate and guide team with Inspection conduct and response activity Maintain line-of-sight to asset quality issues where studies within asset are in multiple models (e.g. AP model, Maintained portfolio) Escalation, Communication, and Governance Guides asset/study team on appropriate escalation pathways Communicates/Escalates Asset / Study quality issues to: Asset-level roles (e.g. DevOps Asset Lead, Clinical Lead) Governance committees as necessary (e.g. QCC, QOC) BPOs for process level issues Alliance Partner Quality group/roles for potential qualifying quality issues as applicable Communicates study team continuous improvement feedback on business processes to BPOs Communicates key quality information (e.g. inspection/audit learnings) across asset/study teams and may serve as asset quality expert and liaison to relevant governance meetings
• Lead or participate in quality-focused meetings for Asset Teams Perform other quality management related or oversight tasks as assigned CQMs may be responsible to provide other CQM centralized services which may include: Quality Compliance Assessments Lead / Contribute to Quality and Compliance Assessments (QCA) planning, conduct and report-out Line Compliance and SOP Review Coordinate and may manage the DevOps Compliance Plan (ADM02); ensure CTPQ training compliance Contribute to the review of new and revised SOPs to determine impact on DevOps business and compliance capability Audit Coordination Point of contact within DevOps and for internal audit groups for process audit planning, conduct and response support; may serve as DevOps/Clinical Audit Coordinator; track Dev Ops / Clinical process audit CAPAs; provide Audit Schedule Root Cause Analysis Facilitation May lead or participate in Root Cause Analysis for ad hoc requests Inspection Readiness Develop and lead strategy for and/or provide Study Team Inspection Readiness (IR) guidance and support; leads teams through pre-submission IR deep-dive Act as CQM Inspection Readiness contact for study teams via the CPM line Inspection
• Support Acts as lead point of contact or supports the lead/main CQM point of contact within DevOps and for MQA when regulatory inspections are announced Coordinates or supports coordination of resources within DevOps/Clinical to ensure successful inspection outcomes and CAPA management for inspection commitments, communicates inspection progress and needs to DevOps/Clinical stakeholders QQI/CAPA Management: Acts and/or supports CAPA Mgmt lead as business line quality group for CAPA Management of Dev Ops / Clinical CAPAs .
• Ensures or supports compliance with CAPA process QQI Case Management o Will or may function as QQI Case Lead: management for Significant Deviations, including investigation/root cause analysis and action development, tracking, and documentation Qualifications Training & Education Preferred: Degree in one of the disciplines related to drug development or business. Advanced or comprehensive knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Prior Experience Preferred Advanced or comprehensive clinical trials experience, especially operational processes and/or systems. Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management Strong influencing skills with ability to influence a broad range of global stakeholders. Strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization Experience of drug development across one or more business lines Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries Ability to work successfully with internal and external partners
• Excellent communication skills adaptable to meet the needs of diverse stakeholder groups Experience of conducting, managing or participating in an audit and/or inspection process Record of achievement and delivery for personal and team goals Ability to balance and prioritize a diverse and demanding workload Works independently and proactively set own work agenda with minimum guidance Competencies: Advanced or comprehensive knowledge in clinical trial development Able to use metrics and related data to determine where quality issues may exist and address appropriately Advanced or comprehensive experience in Quality areas such as: Quality management, quality compliance assessments, audit, inspection, compliance, CAPA management, and inspection readiness fields Knowledge of Pharmaceutical process in these areas
• Project Management skills/experience Ability to provide guidance and instruction in Inspection Readiness and consultation for audit responses Knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines Knowledge of Pharmaceutical SOPs and processes Ability to implement strategies using coordinated and transparent metrics to track and manage compliance Ability to lead cross-line global initiatives or root-cause analysis for quality related process improvement"Facilitate IQMP
• Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) " Quality Gate and/or Quality Compliance Assessments Asset Clinical Quality Management " Advanced or comprehensive clinical trials experience, especially operational processes and/or systems.
Qualifications
Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management " Skills Skills Skills:Category Name Required Experience Areas of Expertise Compliance Yes 6 + Years Technical Skills Quality Audit Reports Yes 6 + Years Additional Skills:Advanced knowledge of Clinical Trial development required. Minimum of Bachelors Degree required. Advanced degree preferred.
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
Quality Assurance Specialist II
Quality assurance manager job in Wayne, PA
Provide support to the Quality Compliance Group by maintaining the day to day data entry for metric systems of key performance indicators within Technical Operations. Interact with Quality business process owners to request metric data and respond to inquiries regarding metric generation. Assist in keeping databases current by maintaining lists critical to the metric program. Provide assistance in Quality Compliance where necessary.
• Experience with Quality Systems required
• Ability to speak effectively and communicate directly with all levels of personnel in a global environment
• Ability to write routine correspondence for internal and external customer communications
• Excellent attention to detail
• Strong organizational skills
• Computer literate-experience with Microsoft Office (specifically Excel, Access and PowerPoint) and TrackWise preferred • Strong self-motivation and ability to work under limited supervision • Ability to work in, and be adaptable to, a diverse, dynamic, and team-oriented environment • Strong compliance mindset
• Ability to work independently
• Ability to solve problems and analyze data
• Work under challenging deadlines and be accountable for completing work within specified time periods
Qualifications
Qualifications:
• Bachelor's degree is required/ Associate's degree is accepted as long as they have relevant Quality Assurance experience
•
Experience in commercial quality assurance (marketed jobs, not just on the clinical and research side) is required
•
Quality Systems experience is required- CAPA, deviation, change control systems
• TrackWise is not required (nice to have)
• 2+ years of experience working within a Pharmaceutical/ Quality Assurance field, no limits when it comes to years of experience
• Open to experience in Medical Devices as well
Additional Information
All your information will be kept confidential according to EEO guidelines.
Quality Assurance Auditor
Quality assurance manager job in Allentown, PA
Under the direction of the Audit Manager, the Quality Auditor has the responsibilities for hosting customer audits, conducting supplier audits, and conducting internal cGMP compliance audits for the company. This role encompasses the entire audit process including support in regulatory and third-party audits. The Auditor responsibilities encompass Sharp Packaging Services, LLC commercial US facilities (Allentown, Conshohocken, and Macungie).
The impact of decisions relating to customer interface, supplier interface and regulatory agency interface could expose the company to significant risk or economic loss.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities related to the Q.A. Auditor position. Other duties may also be assigned.
Host customer audits.
Write responses to customer audit observations.
Support the supplier audit program, including auditing suppliers and writing of supplier qualifications, routine and for cause audit reports.
Support site specific internal audit program, including performing and documenting internal audits.
Review and evaluate the appropriateness of supplier and internal audit responses to ensure effective CAPAs and effectiveness checks are in place.
Participate in regulatory agency inspections.
Coordinate the Root Cause and Corrective Action / Preventative Action (CAPA) process as it relates to all audits and inspections.
Identify areas for continuous improvement as part of audit process.
Remain current with FDA inspectional trends and current industry standards for cGMP compliance.
Follow Sharp SOPs governing internal and supplier audit programs. Follow ISO 13485, principles of cGMPs and industry guidance documents.
Assist in appropriate problem-solving initiatives to address customer or regulatory cGMP issues as requested by management.
Other duties may be assigned as appropriate.
QUALIFICATIONS:
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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES:
None
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
A minimum of one year of experience conducting cGMP compliance audits or comparable industry experience preferred.
Knowledge of FDA cGMPs regulation required specifically 21 CFR 210/211, 820, Part 4
Knowledge of ISO 13485 required
Knowledge of ICH08, 09 and 10 desired.
Knowledge of DEA regulations, ISO 9001 and ISO 15378 desired.
Above average written and oral communication skills required.
Above average organization and planning skills required.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.
Approximately 30 percent travel between sites. Approximately 15 percent travel to supplier sites is required. A valid driver's license is required.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
Auto-ApplyManager, Quality Management Systems
Quality assurance manager job in Phoenixville, PA
The Vacancy
Job Title: Manager, Quality Management Systems & Metrology / LEAN Champion
Department: Quality Overhead
Reports To: Business General Manager
Summary Statement:
Under direction and partnership with the business General Manager, this Management team position has direct responsibility for leading the LEAN journey throughout the business along with discipline ownership of the Quality Management System and Measurement Sciences/Metrology. The LEAN journey focused on providing the overall business LEAN process education and continuous improvement guidance & leadership. The Quality System context defined as: planning and executing product manufacturing and post sales service for portable electronic test instruments and on-line monitoring systems, across the global electricity generation & transmission industry.
Essential Job Responsibilities:
• Serves as the ISO 9000 business management representative, leading all compliance audits.
• Responsible for establishing, implementing, and directing all Quality Assurance efforts.
• Establishes, Monitors, and provides Training for all Quality Management System procedures and processes.
• Establishes, Leads, Monitors internal auditing program.
• Ownership/Responsibility for Quality Management System and associated personnel: (defining needs, staffing, training, directing, coaching, evaluating, compensating, disciplining, enforcement of discipline procedures).
• Ownership/Responsibility for Measurement Science & Equipment Metrology discipline and associated personnel: (defining needs, staffing, training, directing, coaching, evaluating, compensating, disciplining, procedure adherence).
• Oversee/Ensure Quality of all in-house and out-house manufacturing operations, and process/procedure adherence… driving SCARs & CARs as required.
• Establishes & Monitors Supplier Quality Assessment program.
• Participate/Lead Supplier Management meetings (existing partner and new partner audits) driving overall performance requirements and objectives.
• Provide Quality Systems perspective in support of business in-house/out-house sourcing decisions.
• Participate in weekly Class 3/Class 4 status review and planning meetings, facilitating meeting all Quality goals.
• Participate in weekly Change Control Review Meetings, gaining insight & knowledge to ensure Quality of phase in action plans (ECN review/approval).
• Ensure business adherence to appropriate T&M instrument/equipment calibration, inspection, and testing methods.
• Monitor, report and drive continuous improvements throughout the business as LEAN Champion.
• Translate Megger Group Quality & LEAN objectives, actively manage Megger Excellence System charts.
• Provide Leadership & Training to business on Megger Excellence System Quality & LEAN initiatives.
• Participate in the annual business budgeting & review cycles (partnering with General Manager and Controller).
o Capital Equipment Spend, Overhead %, Costs of Warranty, Costs of Poor Quality.
• Monitor monthly Cost Center financial performance, taking corrective actions as needed.
• Other duties as assigned.
Communication skills: Advanced oral & written communication skills.
Interpersonal skills: Professional, respectful, helpful, sincere, and energetic persona, business leader.
Listening skills: Ability to hear & meet needs of business as communicated by business management, employees, and Megger Board leadership.
Problem-solving skills: Advanced problem-solving skills: LEAN process tool kit usage across all disciplines of business: Manufacturing, Supply Chain Management, Material Management, Product Service, Customer Services, Product Development, Product Quality.
Minimum Skill Sets and Competencies:
• Undergraduate degree (Industrial or other Engineering, Business Administration, other). Graduate level degree viewed as differentiator.
• 15 plus years of experience leading Quality and Lean initiatives with an electronic and/or electro-mechanical product manufacturer: High Mix, Low to Medium Volume manufacturing environment.
• 10 plus years of experience: leading/supervising personnel within: Quality & Metrology.
• 5 plus years of experience: using SAP ERP systems in electronic products manufacturing environment.
• Demonstrated experience & advanced working knowledge: new product manufacturing introduction, documentation change control, supplier performance review management, and LEAN problem-solving processes.
• Full working knowledge of ISO9001:2008/2015 certification attainment & maintenance.
• Expert level skills leading business initiative teams comprised of direct and indirect personnel.
• Expert level proficiency with Microsoft Office: Excel, Word, and PowerPoint.
• Attention to detail mentality and appreciation of setting and meeting project deadlines.
Additional Knowledge/Skills/Abilities:
• Visible & vocal advocate of Quality in the workplace.
• Visible & vocal advocate and facilitator of LEAN journey within the workplace (continuous improvement).
• Demonstrated ability to multi-task with demonstrated ability to get things done.
• Demonstrated organizational skills.
External Contacts: Extensive
• Manufacturing & Supplier Partners / Equipment & Tooling Suppliers / Component & Material Suppliers / LEAN Consultants / ISO Registrars
• Global Megger Accounting & Manufacturing teams / Professional Societies
Travel Requirements:
• 0% to 10%
Auto-ApplyQuality Assurance Specialist
Quality assurance manager job in Wayne, PA
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job Description
Job Title-
Quality Assurance Specialist
Location:
Wayne, PA
Duration:
8+ months (possibility of extension)
REQUIRED:
Duites:
Working with quality compliance Team
Helping the day to day data analysis of KPI within the metric systems
Qualifications:
• Bachelor's degree is required/ Associate's degree is accepted as long as they have relevant Quality Assurance experience
• Experience in commercial quality assurance (marketed jobs, not just on the clinical and research side) is required
• Quality Systems experience is required- CAPA, deviation, change control systems
• Track Wise is not required (nice to have)
• 2+ years of experience working within a Pharmaceutical/ Quality Assurance field, no limits when it comes to years of experience
• Open to experience in Medical Devices as well
· Experience with Quality Systems required
· Computer literate experience with Microsoft Office (specifically Excel, Access and PowerPoint) and Track Wise
· preferred Strong self-motivation and ability to work under limited supervision
· Ability to work in, and be adaptable to, a diverse, dynamic, and team-oriented environment Strong compliance mind-set
JOB ROLES
· Help with data analyses and will need some background in Quality and Pharma experience.
· Provide support to the Quality Compliance Group by maintaining the day to day data entry for metric systems of key performance indicators within Technical Operations.
· Interact with Quality business process owners to request metric data and respond to inquiries regarding metric generation.
· Assist in keeping databases current by maintaining lists critical to the metric program.
· Provide assistance in Quality Compliance where necessary.
· Ability to speak effectively and communicate directly with all levels of personnel in a global environment.
· Ability to write routine correspondence for internal and external customer communications.
· Excellent attention to detail.
· Strong organizational skills.
· Ability to work independently.
· Ability to solve problems and analyse data.
· Work under challenging deadlines and be accountable for completing work within specified time periods
Additional Information
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732 - 318 -6506 | (W) # 732-549-2030 - Ext - 324 | (F) 732-549-5549
Email id - seema @irionline.com| www.irionline.com
LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
Quality Manager
Quality assurance manager job in Limerick, PA
Dometic is a global market leader in the mobile living industry. Millions of people around the world use Dometic products in outdoor, residential, and professional applications.
Our Marine organization is a trusted provider of innovative solutions for the worldwide boating and boat building industry, and we recently expanded our scope to lead the boating industry into an electrified future. Dometic has won numerous NMMA Innovation Awards over the years and we are always striving for new ways to make boating easier, safer, and more enjoyable.
We are a journey of continuous growth - now looking for our next star - a passionate Quality Manager. This position reports to the General Manager and will work in Limerick, PA
About the position
As a Quality Manager in the Limerick, PA team, you will be involved in managing the overall quality control for manufactured products and compliance with the quality management system.
Your main responsibilities
Promote quality achievement and performance improvement across the organization.
Lead and organize formal/informal problem solving in areas of scrap, process capability, warranty, etc., using; 8D, Shanin Red X, 3L5W and A3 reporting formats as examples.
Develop and measure quality goals, KPI's and targets in the global and local organization's strategic plan.
Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.
Assess product specifications and customer requirements.
Ensure compliance with national and international standards.
Partner with engineering, manufacturing and purchasing to formulate and agree on comprehensive quality procedures. Liaise with other managers and staff, particularly in areas such as design, production and purchasing.
Work closely with purchasing employees to establish supplier quality performance criteria and monitor supplier performance.
Assess suppliers' product specifications and quality plans.
Define processes and procedures in conjunction with operating employees.
Supervise internal auditing and continual improvement to product or services.
Work methodically to establish a clearly defined quality management system.
Lead and coach technical employees in carrying out tests/checks, in a laboratory environment. Ensure tests and procedures are properly understood, carried out, evaluated and that product modifications are investigated if necessary.
Act as key contact with customers' auditors and being responsible for ensuring the execution of corrective actions and ongoing compliance with customers' specifications.
Write technical and management system reports that predict trends that will affect improvement of quality.
Pinpoint relevant quality-related training needs.
Consider application of environmental and health and safety standards.
Customer and Executive level presentation experience is paramount.
Complete additional job duties and assignments.
What do we offer?
You are offered an interesting role in a dynamic, fast paced and global environment with great opportunities to grow and take on new challenges. The growth at Dometic is continuous - which gives you great possibilities to evolve with the company.
Medical/Dental/Vision Insurance
Employee Assistance Program (EAP)
Disability insurance (STD/LTD)
401 (k) with company match
PTO
Company defined holidays and two floating holidays for you to use as you choose
Paid maternity/paternity leave
Tuition assistance
Membership reimbursement (wholesale club and gym)
Employee discounts on our incredible products
Opportunities to make an impact
Quality Manager
Quality assurance manager job in Cressona, PA
Hydro Extrusions is a world-leading aluminium extrusion business counting around 100 production sites in 40 countries and employing 20,000 people. Through our unique combination of local expertise, global network, and unmatched R&D capabilities, we can offer everything from standards profiles to advanced development and manufacturing for most industries. Since 1905, Hydro has turned natural resources into valuable products for people and businesses with focus on a safe and good workplace for our 30,000 employees in more than 140 locations.
Job Location: Cressona, PA
Hydro employees can enjoy several benefits including:
* Retention Bonus (for external hires)
* Medical, Rx, Dental, Disability, Life Insurance, Flexible Spending Accounts
* Retirement Savings Plans with Company Match/Contributions
* Education Assistance
* Bonus Plan Eligibility
* Referral Bonuses
* Parental Leave
* On-site Gym & Café
Job Summary:
This critical position oversees the work and evaluates the effectiveness of quality resources, ensuring compliance with all quality systems and industry (Mechanical/OES labs, pyrometry, and other Aluminum Industry) requirements. This position is also responsible for timely resolution of customer claims with the expectation of using engineered solutions to implement irrevocable countermeasures to correct any product, system or process anomalies. The Quality Manager reports directly to the Plant Manager and functionally to the HE NA Director, Quality.
Required Education/Experience:
* Minimum five (5-10) years of experience managing quality and/or continuous improvement functions in the heavy manufacturing industry.
* Experience in external quality roles - depth and breadth of exposure to successful quality systems implementation and management in heavy manufacturing.
* Minimum Bachelor of Science degree in Engineering or equivalent technical degree; preferred engineering discipline in metallurgical, materials science or mechanical (in that order).
Demonstrated Abilities:
* Demonstrated intensity and tenacious approach to managing safety. Understands the critical link between safety and quality.
* Focus on diversity of industrial exposure with a strong quality / improvement background and process-based thinking.
* Demonstrated proficiency in disciplined, systemic problem solving. Understands A3 / PDCA.
* Demonstrated proficiency in formal quality systems deployment (ISO 9001 / IATF 16949) including automotive quality standards (e.g. CQI-9).
* Demonstrated proficiency in working to enhance integrity and scope of process measurements.
* Demonstrated proficiency in working with customer and industry specifications and new product launch processes (APQP, PPAP).
* Demonstrated proficiency in coaching, teaching and developing employees in needed skill sets that contribute to their personal betterment and to the betterment of the company.
* Demonstrates critical focus on customer-facing issues.
Job Responsibilities:
* Provides a safe working environment for all in the department and enable professional growth.
* Leads a team of Quality professionals to ensure the business is achieving its quality goals and improvement plans.
* Directs the site's technical strategy in support of market and product development and plays a major role in shaping business strategy and developing policy for the site.
* Facilitates decision making processes in the development of the business plan and critical operational issues.
* Focuses on the strategic outlook and plans for a product or service capability, technical or administrative functions, or production capability.
* Drives process improvement initiatives to reduce customer complaints and internal scrap.
Equal opportunities
Hydro in North America is an Equal Opportunity Employer where all phases of employment are based strictly upon the qualifications of the individual as related to the work requirements of the position. This policy is applied without regard to race, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, veteran status, marital status or any other category protected by law. We strive to provide equal opportunities for all to contribute and succeed with us.
If you need an accommodation in order to complete the application, please contact Hydro Recruiting via email at **********************************
Possible work locations
Why Hydro?
Are you looking to make a real impact? For over a century, our people have been the driving force in solving some of the world's most pressing issues - and we hope you'll join us in solving the next century's. Whether you're working to close the loop at one of our recycling facilities or ensuring efficient renewable energy processes to decarbonize aluminium production, your contributions make an impact in our shared purpose of propelling our industries and the world into a greener future.
Why Hydro?
Are you looking to make a real impact? For over a century, our people have been the driving force in solving some of the world's most pressing issues - and we hope you'll join us in solving the next century's. Whether you're working to close the loop at one of our recycling facilities or ensuring efficient renewable energy processes to decarbonize aluminium production, your contributions make an impact in our shared purpose of propelling our industries and the world into a greener future.
A job where you make a difference
A key part of succeeding in this mission involves encouraging a collegial environment where our differences are acknowledged as our greatest competitive advantage.
Your diverse perspective makes us stronger. Our global diversity, inclusion and belonging program enables us to cultivate a high-performing and inclusive workplace where everyone feels valued.
Your career journey is unique. We strive to provide you with the support needed to achieve your full potential. With our global reach, inclusive culture, and cutting-edge technology you'll have the opportunity to build a career that aligns with your strengths and passions.
Join our global community of over 30,000 people with a presence in 40 countries and united by the values of Care, Courage and Collaboration. At Hydro, you have the chance to make a difference in the industries that matter. Explore our world and the heart of our operations.
A job where you make a difference
A key part of succeeding in this mission involves encouraging a collegial environment where our differences are acknowledged as our greatest competitive advantage. Your diverse perspective makes us stronger. Our global diversity, inclusion and belonging program enables us to cultivate a high-performing and inclusive workplace where everyone feels valued.
Your career journey is unique. We strive to provide you with the support needed to achieve your full potential. With our global reach, inclusive culture, and cutting-edge technology you'll have the opportunity to build a career that aligns with your strengths and passions. Join our global community of over 30,000 people with a presence in 40 countries and united by the values of Care, Courage and Collaboration. At Hydro, you have the chance to make a difference in the industries that matter. Explore our world and the heart of our operations.
A job where you make a difference
A key part of succeeding in this mission involves encouraging a collegial environment where our differences are acknowledged as our greatest competitive advantage. Your diverse perspective makes us stronger. Our global diversity, inclusion and belonging program enables us to cultivate a high-performing and inclusive workplace where everyone feels valued.
Your career journey is unique. We strive to provide you with the support needed to achieve your full potential. With our global reach, inclusive culture, and cutting-edge technology you'll have the opportunity to build a career that aligns with your strengths and passions. Join our global community of over 30,000 people with a presence in 40 countries and united by the values of Care, Courage and Collaboration. At Hydro, you have the chance to make a difference in the industries that matter. Explore our world and the heart of our operations.
About Hydro
* Hydro is a leading aluminium and renewable energy company committed to a sustainable future
* Founded: 1905
* Number of employees: 32,000
* Company presence in around 40 countries worldwide
* President and CEO: Eivind Kallevik
Learn more about Hydro
Get to know us
Purpose and values
Hydro worldwide
History and heritage
Career areas
Meet our people
Hydro's talent community
Can't find the right job? Be the first one to learn about new job opportunities that might be a perfect fit for you.
Join Today
Hydro's talent community
Can't find the right job? Be the first one to learn about new job opportunities that might be a perfect fit for you.
Join Today
Nearest Major Market: Allentown
Quality Supervisor
Quality assurance manager job in Reading, PA
How You Will Make an Impact The Quality Supervisor is responsible for the daily oversight and process effectiveness of quality assurance systems. They will engage and implement policies and procedures that improve quality awareness, controls, and accountability. In addition, this position will ensure that components are being tested, repaired, and overhauled in accordance with the appropriate technical data, as well as enforce a high standard of cleanliness and functionality not only of the parts inspected, but also in the workplace.
The Nuts and Bolts
Maintain the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for accurate completion and periodic reports and metrics
Monitor, evaluate and assign corrective actions to appropriate department heads for completion, as well as follow through and verify the solutions by auditing the efficiency of corrective actions
Assist and/or develop, monitor, and evaluate quality PDCA's as directed by management
Report ongoing activities to management and keep the company continuous improvement efforts on track
Collect and analyze critical quality data, metrics, KPI's, etc.
Provide monthly reports on problem areas (Pareto, Trend, etc.) to management
Assist Quality Manager in the development of Surveillance Plans in all departments within the plant
Develop internal process audits for all areas of focus in each department per senior management
Conduct internal process audits for all areas of focus in each department within the plant
Train quality team members on the proper internal process auditing process and techniques
Work with engineering, continuous improvement, and operations to help improve products and process using DOE, PFMEA, SPC, 6 Sigma tools
Develop critical to quality standards and procedures to sustain a high-level quality product
Develop quality documents which are consistent with all other documentation regarding uniformity, to support the organizational effort to implement a strong Quality Management System (QMS)
Direct and support quality team members engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products
Direct and support rework team members to ensure a high level of quality product is delivered, and ensure the department meets or exceeds daily objectives
Plan, promote, and coordinate training activities related to product quality and reliability
Skills and Abilities:
Knowledge of Quality Systems and auditing of those systems
Possess excellent project management and prioritization skills
Proficient in developing and leading statistical sampling plans
The ability to work collaboratively with others toward mutual objectives
Excellent listening and communication skills
Ability to establish and maintain new systems and processes
Proficient in the operation of computers, Microsoft Office Products, and other related software
Possess good technical writing skills
Knowledge of Statistical Process Control (SPC)
Must possess strong problem-solving, leadership and multi-tasking skills
Supervisory responsibilities:
Team of Production Hourly Team Member
Position Qualifications & Requirements:
• Three (3) years' experience as a Quality Supervisor, or related technical position required
• ISO 9001:2015, and Quality Management Systems (QMS) experience preferred
Certification/License:
• Lean/5S/6 Sigma Certifications a plus
• ASQ or Other Quality Certifications Preferred
How We Make an Impact
At Reading Truck, we have more than 65 years of industry leadership in the manufacture, distribution, and enhancement of work truck bodies. We continue to experience rapid growth through our expanding network of more than 20 locations across North America. Take the next step in your career and come get paid to play with trucks!
Some of Our Total Rewards
We offer big company perks with small company culture:
Comprehensive benefits package including Medical, Dental, Vision and Life
401(k) Savings Plan with Company Match
Paid Parental Leave
Tool Purchase Program
Tuition Reimbursement
Paid Time Off and 10 Observed (Paid) Holidays
Generous Footwear, Eyewear, and Safety Equipment Discount Program • Paid Training and Development Programs
J.B. Poindexter & Co., Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
AGENCIES / THIRD PARTY RECRUITING FIRMS: Any unsolicited submissions received from third party agencies will be considered property of Reading Truck, and we will not be held liable for any fees related to those submissions.
To learn more about Careers with Reading Truck visit our careers page *******************************************
Virtual Job: false
Laboratory Operations Manager OR Lab Manager in Pennsylvania
Quality assurance manager job in Allentown, PA
Affordable cost of living below the national average with affordable housing.
Offers a balance of urban and rural benefits
Close proximity to Philadelphia, Harrisburg and Allentown
Position Highlights:
Award Winning Hospital offers a wide variety of acute care and outpatient services
Hospital is part of a growing health system
Monday through Friday, Day Shift position
Reports to Laboratory Director
Requirements:
Bachelor's degree or Master's degree preferred.
ASCP certification (or equivalent) required
Must have at least 5 years of laboratory experience including previous supervisory experience
Offering highly competitive compensation and benefits packages! Benefits vary from facility to facility but all include health, dental and vision benefits; generous PTO and holiday packages; Life Insurance; retirement benefits; educational benefits and/or relocation assistance or sign on bonuses!
Interested in learning more? Contact Andrea at andrea@ka-recruiting.com or call/text 617-746--2745.
ACC 25131861
Quality Assurance Specialist - Allentown PA
Quality assurance manager job in Allentown, PA
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Let's do this! Let's change the world!
This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation.
Responsibilities:
Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
Review documentation associated with receipt, storage, and distribution
Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
Perform routine Quality Assurance assessments and provide direct operational oversight
Offer leadership, guidance, mentorship, and training to staff and partner organizations
Manage oversight of logistic and transportation service providers
Provide expert advice on quality matters to operational teams and cross-functional groups
Ensure staff complete necessary training related to Amgen business operations
Achieve established metric targets and develop standardized approaches for tracking progress
Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
Participate in quarterly business and quality reviews and address any service failures with LSPs
Present updates on LSP Quality Management System health and initiatives at management reviews
Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
Support internal and external audits and inspections as a member of the audit/inspection team
Implement business continuity plans for services and processes
Form strategic partnerships with internal customers and external vendors to ensure operational success
Integrate risk management strategies into overall supply chain management
Lead initiatives, programs, and projects targeting operational improvements
Develop solutions that are comprehensive, practical, and align with functional goals
Perform additional duties as assigned by management
Additional Qualifications/Responsibilities
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master's degree and 2 years of quality assurance experience OR
Bachelor's degree and 4 years of quality assurance experience OR
Associate's degree and 8 years of quality assurance experience OR
High school diploma / GED and 10 years of quality assurance experience
Preferred Qualifications:
Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
Expertise in managing deviations, change controls, and CAPAs
Proficiency in Veeva, SM LIMS, and ERP systems
Knowledge of industry standards (GMP, GDP, Import/Export)
Commitment to exemplifying Amgen's core values
Demonstrated self-leadership and motivation
Strong critical thinking skills
Ability to evaluate compliance issues and engage with regulatory inspectors
Experience managing multiple priorities within a dynamic environment
Direct experience with drug substances and/or drug products
Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
Track record of representing an organization during regulatory interactions
High proficiency in Microsoft Excel, Word, and PowerPoint
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Quality Control Manager
Quality assurance manager job in Boyertown, PA
Job Description
Under the supervision of the Vice President of Quality, performs all job functions necessary to provide support for Quality Inspectors in the performance of their duties. Assures that our “products” meet the quality standards defined by the Customer and/or Drug Plastics.
ABOUT US:
Drug Plastics is a competitive, growing company that wants people who are eager to share their knowledge, talent, and experiences. We are the premier manufacturer of bottles and closures for medicinal, wellness, and lifestyle products.
PERKS with Drug Plastics:
Vacation, Sick, and Holiday time
Career Advancement Opportunities across our 8 Plants
On the Job Training
Temperature Controlled Work Environment
Medical, Dental, Vision & 401K Benefits
A company created and drive by family qualities!
Commitment to Sustainability:
All plants 100% renewable/carbon-free sourced energy.
Voluntarily disclose our environmental data through CDP's platform
Reduced scope 1 and scope 2 emissions by over 90% since 2015.
Committed to net-zero emissions by 2050.
Minimum Qualifications:
Bachelor's Degree preferably with a major in Math or Science
Vision Correctable to "20-20"
Required Skills:
Ability to communicate effectively (written and verbally)
Apply math and science skills to perform basic statistical calculations
Working knowledge of Microsoft Suite (Excel, Word, Outlook, etc)
Organizational and Time Management Skills
Some Responsibilities Include:
Promote Positive Employee Relations
Complete and Review all required daily production reports
Review and approve Quality Control Inspector timecards on a weekly basis
Supervise Quality Inspectors to insure all quality and production standards are maintained
Attend Priority Meetings
Prepare and maintain supporting documentation for all manufacturing orders including Product Quality Standards, Quality Cards, Labels, Manufacturing Orders, Product Drawings, Bottle Inspection Reports etc.
Maintain all certificates of analysis/compliance for raw materials
Perform internal plant audits and assist in correcting any deficiencies
Jointly conduct root cause analysis and Corrective Actions & Preventative Actions (CAPAs) for all Customer complaints
Drug Plastics & Glass Company Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, gender, gender identity, sexual orientation, national origin, genetic information, veteran, or disability status.
#IND1
Quality Assurance Coordinator (IDD Services)
Quality assurance manager job in Orwigsburg, PA
at Community Options, Inc.
Community Options, Inc. is a national non-profit agency providing services to individuals with disabilities in 12 states. We are actively seeking a dedicated IDD Quality Assurance Coordinator in Lancaster, Berks, and Schuylkill, PA. The Quality Assurance Coordinator is responsible for monitoring the systematic operations of the residential and vocational programs. This person will serve as a liaison between the local office and the national office.
Starting pay is $55,000/per year
Responsibilities
Schedule and conduct QA audits of financial, personnel files to include training records, medication administration records, medical records, Therap, and billing documentation
Conduct physical site inspections of homes and programs
Conduct 30-day initial audit of all new homes and programs
Audit individuals' in-house accounts to verify that required documentation is maintained, accounts are monitored by the designated staff and balances are correct
Communicate findings of audits to the Regional/State Director, Executive Director, and National Compliance and QA Director
Recommend any necessary changes in current policy and procedures
Additional tasks and responsibilities may be assigned
Employee must cooperate with the license and department staff in any inspection, inquiry, or investigation
Minimum Requirements
Bachelor's degree in a related field and three years of relevant experience
Knowledge of 6400 regulations
Valid driver's license with a satisfactory driving record
Commitment to and knowledge of community-based support for persons with disabilities
Working knowledge of management of an effective QA program, including training, monitoring, conducting and documenting investigations, addressing violations, and monitoring corrective actions
Independent judgment is required to plan, prioritize, and organize diversified workload
Proficient with Microsoft Office 365
Knowledge and understanding of local regulatory agency operations
Employment is contingent upon successful completion of checks of criminal background, central registry, child abuse registry, and drug testing
Why Community Options?
Competitive Insurance Benefits (Medical, Dental, Vision)
Paid Holidays-Including a Birthday Holiday
Generous PTO
Employee Incentive & Discount Programs
403b Retirement Plan
Incredible career growth opportunities
Please Visit Our Website to Complete an Online Application! Careers.comop.org
Community Options is an Equal Opportunity Employer M/F/D/V
#IND-SK
Auto-ApplyQuality Control Inspection Supervisor- Split Shift
Quality assurance manager job in Jonestown, PA
Our Jonestown Distribution Center, a 218,000 sq. ft. refrigerated facility operating 24/7, is currently seeking a Quality Control Inspection Supervisor to join our team. The essential function of this position is to develop and lead Quality Control Inspectors to ensure that all product meets customer specifications. This role will collaborate with Commodity Inventory Controllers and Production Management and other warehouse personnel to proactively prevent rejections.
Split Shift Schedule:
Monday, Tuesday, Wednesday, Thursday, Sunday
11AM-8:30PM
Primary Responsibilities:
* Ensure that all product meets or exceeds customer specifications.
* Look at ways to reduce customer rejections and waste while increasing efficiency.
* Monitor customer satisfaction by gathering relevant data and producing statistical reports.
* Monitor product traceability and work with CIC's to eliminate product that doesn't meet specifications.
* Proactively finds solutions to product issues and establishes processes to prevent future issues.
* Supervise Quality Control Inspectors to ensure that all product inspections are being performed, labeling specification are adhered to, and non-conformance product is pulled and corrected.
* Train, coach, and teach Quality Control Inspectors about our product, product defects, product quality concerns, and customer expectations.
Knowledge, Skills, and Abilities Required:
* College degree or 2 years of experience in the quality or related field, required
* Must be a self-starter and willing to work flexible hours; Rotational shifts, weekends, holidays, etc.
* Proficiency in use of English language with the ability to communicate effectively and professionally.
* Spanish as a second language would be an asset.
* Inspection/audit experience, working in software applications are considered assets
* Highly proficient in computer-use skills (MS Office: Word, Excel and PowerPoint).
* Strong organizational, analytical and problem-solving skills. Need to be creative, adaptable and able to accurately work with a sense of urgency.
* General knowledge of general laboratory best practices, highly proficient in ability to document and work within GMPs and SOPs.
* Ability to effectively follow-up and handle multiple projects with strong personal time-management skills.
* Keep all company information confidential and protect proprietary information.
* Understand the importance of interpersonal skills and the ability to work with multiple departments throughout the company in a positive and efficient manner.
* Valid driver's license and clean driving record is required.
Working Conditions:
* Must be able to work in our refrigerated warehouse with 50° F temperature-controlled zones.
* Must be able to lift up to 30 lbs. with or without accommodation
* Position requires sitting, standing, walking and bending, squatting, and crawling on a regular basis
We are pleased to offer the following Benefits:
* Weekly pay with direct deposit or debit card options
* Medical, Dental, Vision Health Insurance Plans Life Insurance
* 401K and Life Insurance Plan Options
* Paid time off and holiday pay
* Employee Engagement & Recognition Programs
* Opportunities for growth and advancement
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