Quality Control Manager
Quality manager job in Cary, NC
At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Quality Control Manager to join our talented team at our office located in Cary, North Carolina.
In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance (QA/QC) program for ongoing Construction Projects. This is a leadership role responsible for working with the On-Site Construction Management Team to ensure the established project standards are followed.
Additional Responsibilities
Develops, plans, manages, and administers the implementation of project-specific Construction QA/QC Plans with the CM team, contractors, and clients.
Trains the project team on their criteria and implementation.
Develops special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC project-specific plans.
Reports and publish quality reports, audits, and initiatives to the Project Manager and review with the project team prior to publication.
Ensures Corporate Quality initiatives and goals are achieved.
Develops a system to compile, monitor, track, and confirm deficiencies and successes of work performed by direct-hire and subcontract work crews.
Evaluates testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented.
Reviews utility matrices developed to start up and commission systems and skids.
Directs the tracking of deficiencies, test results, or other regularly reported quality control data.
Manages non-conformance reporting activities and tracks efficiencies from identification through resolution.
Monitors performance of quality control systems to ensure effectiveness and efficiency.
Verifies that the construction of systems and equipment are installed in accordance with approved construction documents.
Reviews plans and specifications to ensure requirements are met for each construction process.
Understand and apply federal, state, and local codes, policies, laws, and regulations.
Identifies quality problems or areas for improvement and recommends solutions.
Assists in performing system walk downs/final inspections; closeout and startup; establishes system completion punch list items; and, ensures all deficiencies are corrected.
Attends pre-construction and construction meetings noting areas/topics that may present future problems/risks and present to the project manager for consultation.
Implements the corporate safety culture and principles into the QA/QC programs.
Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights!
Qualifications & Requirements
B.S. in a Science, Engineering, Construction management, or related field.
Quality Assurance and Quality Control Management training and experience with 15 years of field experience in construction and/or engineering.
Strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry along with the ability to interpret complex issues and provide recommended courses of action.
Proficient skill level in Microsoft Office Suite.
Preferred Qualifications
First Aid/CPR training.
Primavera P6 and MS Project knowledge.
Commissioning and System startup experience.
Safety
You will travel 50% of the time, or as necessary to complete duties.
You may be assigned to a client for an extended period of time (1-2 years).
OSHA 10 certification (IPS will provide tools) must be maintained during employment.
Overnight travel is possible.
You will focus on construction field activity and office time will be limited.
You will visit Client sites and will be required to adhere to stated safety rules.
This position is a safety-sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Quality Assurance Manager
Quality manager job in Biscoe, NC
Summary: Our client is a tier 1 supplier who is looking to add a Quality Manager to their team. The Quality Manager will develop, implement, and administer the Company's quality programs to achieve the mission, vision, values, and goals of the organization. This will include selecting, developing, implementing, and overseeing appropriate quality assurance programs and procedures are consistent with overall company objectives, including IATF.
The Quality Manager will have 5+ years of manager or director level experience.
Quality Manager Job Requirements:
Bachelor of Science degree in Metallurgical Engineering or Material Science or associate degree in applied science
Minimum of five (5) years' experience in Iron Foundry (preferred) Quality or Process Control with metallurgical decision responsibility.
Minimum of five (5) years' experience in Iron Foundry (preferred) Quality or Process Control position.
Quality Manager Responsibilities:
Maintain communications with customers on quality related issues
Act as the advocate for customers on all matters related to quality.
Set Metallurgist parameters throughout process.
Assign customer service responsibilities to plant staff members, as necessary.
Follow-up to ensure customer visits are performed and appropriate documentation is maintained.
Collect, analyze, and retain a wide variety of statistical and related quality assurance data.
Make recommendations on the basis of analysis or take action within the limits of standard practice.
Ensure proper inspection of all incoming material and completion of resulting documentation.
Take appropriate action or prepare recommendations on the basis of inspection findings.
Maintain close contact with operations and scheduling personnel to anticipate and resolve quality problems.
Review all casting specifications on new work to ensure customer requirements can be met.
Complete a wide variety of reports, projects, or studies to continuously improve quality and reduce costs.
Initiate and direct audits and quality reviews in accordance with the requirements of IATF and GRIP to ensure foundry operations and process controls are completed in accordance with the quality manual.
Lead the Quality steering committee.
Ensure a competent staff is maintained to meet both short and long-term objectives
Provide for staff development and growth.
Prepare the department budget and administer and control the approved budget during the business year.
WHO WE ARE?
Choosing the Hire Road is about shared success, active and committed partnerships and relationships that last. Hire Road is solely focused on connecting highly skilled professionals with leading organizations. We are a solutions-based, results-oriented staffing company specializing in a wide range of industry specific practices. To put it simply, we recruit, screen and hire talented people for temporary and full-time positions.
This classification description is intended to indicate the general kinds of tasks and levels of work difficulty that are required of positions given this title and should not be construed as declaring what the specific duties and responsibilities of any position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct and control the work of the employees under her/his supervision. The use of a particular expression or illustration describing duties shall not exclude other duties not mentioned that are of a similar kind or level of difficulty.
Equal Opportunity Employer
GxP Quality Auditor / Sr Quality Lead
Quality manager job in Greenville, NC
GxP Quality Auditor / Senior Quality Lead
Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year
A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity.
Position Summary
The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment.
Key Responsibilities
Coordinate between site and global teams to align SOPs and bracketing strategy
Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements
Develop and defend bracketing justification for multiple manufacturing lines and isolators
Facilitate governance meetings, escalate risks, and report status to leadership
Review and approve protocol templates, summaries, and reports for finalization
Qualifications
Bachelor's degree in a scientific or industry-related field
Minimum 7+ years of experience in pharmaceutical manufacturing or compliance
Proven experience developing bracketing and matrixing strategies
Strong knowledge of FDA, EMA, and HMRA regulations
Familiarity with cGMP and facility/equipment validation requirements
Excellent technical writing and communication skills
Ability to work full-time on-site in Greenville, NC
Why Join This Team?
Competitive compensation and performance-based incentives
Comprehensive benefits package including medical, dental, vision, and retirement plans
Paid time off, holidays, and professional development opportunities
Collaborative culture with strong career growth potential
Project Manager 2 - Quality Engineering/Quality Management Platform Analyst
Quality manager job in Wilson, NC
Immediate need for a talented Project Manager 2 - Quality Engineering/Quality Management Platform Analyst. This is a 12 Months Contract opportunity with long-term potential and is located in Wilson, NC(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job Diva ID: 25-94614
Pay Range: $51 - $53/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:
Train on and establish an account in Kneat,
Evaluate how to optimally apply the system,
Construct the needed infrastructure in our workspace and roadmap the execution
Available to work full-time (40 hrs./week) with reliable transportation to and from work
Must be available to work Monday through Friday 8AM to 5PM Must be able to work in the US and must not require sponsorship for employment visa status now or in the future (e.g., FI, H1-B status).
Key Requirements and Technology Experience:
Key Skills; Experience using Kneat, MS word and in writing method validation or transfer protocols
BS Experience and Skills: Required:
Incumbent must be proficient with Word, Excel, Power Point, have the soft skills needed to nurture change, as well as, the acuity to use software nuanced to operate in a regulated environment.
Generally Requires 8-10 Years Work Experience
Kneat experience required
A Major in Bio-Medical Engineering, Chemistry or Biology Other
Our client is a leading Pharmaceutical 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, 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.
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.
Quality Engineer
Quality manager job in Gastonia, NC
Key Responsibilities
Develop, implement, and maintain quality control processes for metal stamping, welding, CNC machining, and coating operations.
Investigate and resolve quality issues using root cause analysis tools and support corrective and preventive actions (CAPA).
Perform and support internal and external audits to ensure compliance and readiness.
Monitor, analyze, and report key quality metrics, including PPM, scrap rates, and customer complaints.
Collaborate with engineering and production teams to ensure built-in quality throughout all manufacturing processes.
Lead or support continuous improvement initiatives using Lean and Six Sigma methodologies.
Participate in APQP activities and prepare required documentation, including PPAP, FMEA, Control Plans, and Work Instructions.
Ensure compliance with ISO 9001 and IATF 16949 standards across operations.
Manufacturing Quality Engineer
Quality manager job in Charlotte, NC
The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:
What You will Do:
Quest Global is seeking a highly organized and detail-oriented Quality Engineer to join our team. In this role, you will ensure compliance with quality standards and continuous improvement within Gas Turbines Rotor Components Machining Department. This role involves monitoring manufacturing processes, conducting root cause analysis, and implementing corrective/preventive actions to maintain product integrity and customer satisfaction.
The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:•
What You Will Do:
Quality Assurance & Compliance
Develop, implement, and maintain quality control procedures for rotor components machining processes.
Ensure adherence to Siemens Energy quality standards and applicable industry standards.
Inspection & Documentation
Review engineering drawings, specifications,
Prepare and maintain quality documentation, inspection reports, and RCAs, Corrective / preventive action records.
Root Cause Analysis & Problem Solving
Lead investigations using RCA, 8D, and CAPA methodologies for non-conformances.
Drive corrective and preventive actions to eliminate recurring issues.
Process Audits & Continuous Improvement
Conduct internal/process audits of machining processes and identify improvement opportunities.
Support Lean initiatives and process optimization projects.
Collaboration & Communication
Work closely with manufacturing engineers, machinists, and supervisors to resolve quality issues.
Provide technical guidance and training on quality standards and best practices.
What You Will Bring:
Bachelor's degree in mechanical or manufacturing engineering.
Minimum 7 years of experience in quality engineering within a machining or heavy manufacturing environment.
Proficiency in quality tools: RCA, FMEA, PPAP and SPC
Good understanding of CAD/CAM, CNC programming, and interpreting technical drawings with GD&T
Strong knowledge of machining processes, CNC, CMM and precision components.
Familiarity with SAP or similar ERP systems and Microsoft Office Suite.
Certification in Six Sigma will be an added advantage
Strong interpersonal skills
Analytical and problem-solving skills with attention to detail.
Ability to interpret complex engineering drawings and specifications.
Strong communication and interpersonal skills for cross-functional collaboration.
Knowledge of industry standards and regulatory requirements for turbine components.
Ability to apply continuous improvement methods to increase manufacturing quality, efficiency, reliability, and cost effectiveness.
Experience with advanced manufacturing processes
Candidate should be familiar with Lean and or Six Sigma philosophies and their application in process capability and improvement
Pay Range: (75K to 80K ).
Compensation decisions are made based on factors including experience, skills, education, and other job-related factors, in accordance with our internal pay structure. We also offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan.
Work Requirements: This role is considered an on-site position located in Charlotte, NC.
You must be able to commute to and from the location with your own transportation arrangements to meet the required working hours.
Shop floor environment, which may include but not limited to extensive walking, and ability to lift up to 40 lbs.
Quality Manager
Quality manager job in Durham, NC
Working at Freudenberg: We will wow your world!
Responsibilities:
Maintain & Elevate the QMS: Drive continuous improvement and ensure compliance with ISO 9001 and other industry certifications.
Own the Audit Process: Plan and execute internal audits, facilitate third-party and customer audits, and lead corrective actions with precision.
Run the Quality Lab: Oversee daily lab operations, including product testing, inspections, and equipment calibration.
Partner with Leadership: Report on QMS performance and improvement opportunities to senior management, influencing strategic decisions.
Keep Customers at the Heart: Promote customer requirements across the organization to ensure every product meets expectations
Qualifications:
Bachelor's degree in a relevant technical field (e.g., Engineering, Science) or equivalent experience
5+ years experience in a quality leadership or management role
Proven experience implementing and maintaining an ISO 9001 compliant QMS
Experience managing quality control in a manufacturing environment or testing laboratory
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg Performance Materials LP (USA)
Auto-ApplyDirector, Parenteral Sterility Assurance
Quality manager job in Raleigh, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
Responsibilities:
* Assess differences in current sterility assurance programs across the sites and drive harmonization
* Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
* Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
* Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
* Building, maintaining, and growing capability across the organization in the sterility assurance space
* Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
* Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
* Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
* Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing.
* Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
* Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
Basic Qualifications:
* BS Degree required.
* MS/PhD in a biological science preferred.
* 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred.
* 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred.
* Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
* Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
* Strong written and oral communication skills
* Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
* Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
* Demonstrated experience influencing site and network leaders to advance technical agenda projects
Additional Preferences:
* Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
* Support the establishment of a sterility assurance network or hub in global TSMS
* Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
* Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space
* Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance
* Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
* Strong capability to influence personnel and management across the organization
* Close interaction with quality to enable internal audits that identify risks
* Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.
Additional Information:
* Approximately 25% travel
Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$133,500 - $246,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyQC / Quality Manager
Quality manager job in North Carolina
This position performs senior-level quality control functions, overseeing comprehensive quality management responsibilities within a manufacturing environment. Duties include maintaining certifications, managing customer complaints, conducting inspections, programming inspection equipment, and supporting audits. The role requires deep technical expertise and knowledge in specialized functions to support the development of policies, procedures, and innovative approaches for achieving strategic business goals.
Responsibilities:
The tasks listed below are representative of this role and not intended to cover every possible assignment. Management may assign additional functions as deemed appropriate.
Oversee, schedule, and prioritize all inspection activities, including First Article Inspections (FAIs) and Coordinate Measuring Machine (CMM) programming
Track, document, and trend customer complaints, non-conformances, and Corrective and Preventive Actions (CAPAs)
Lead process validations, special requirements capability studies, Gage Repeatability and Reproducibility (Gage R&R), and statistical analyses as required
Maintain and manage quality system documentation, including procedures, forms, and work instructions; ensure ongoing compliance with ISO 13485
Oversee calibration programs and ensure proper gage calibration
Manage Engineering Change Orders (ECOs), customer-driven revisions, and disposition of Work-in-Process (WIP) and inventory items
Authorize the Material Review Board (MRB) for disposition decisions
Perform part inspections and sort customer products as needed
Coordinate internal and external audits; host customer audits as necessary
Perform administrative Human Resources (HR) tasks using a Human Resources Information System (HRIS)
Required Experience:
Associates degree or technical certificate in programming, process engineering, or related field
8+ years of experience in quality control, including 3 years in a supervisory role
Required or must obtain: Lean certification, Black Belt training, and GD&T (Geometric Dimensioning & Tolerancing) certification
Knowledge, Skills, and Abilities
Expertise in engineering principles and geometric dimensions and tolerances
Proficient in the use of measurement tools: calipers, micrometers, depth gauges, indicators, and Go/No Go gauges
Working knowledge of ISO 13485 and FDA 21 CFR Part 820 standards (training provided if needed)
Strong computer skills, including Microsoft Office (Word, Outlook, Excel), Adobe PDF, SolidWorks, In-Spec metrology software, and ERP systems
Proficient in mathematics including geometry, algebra, and metrics for specification calculations
Skilled in prioritizing and managing multiple projects to meet quality and customer goals
Capable of maintaining performance under pressure and adapting to change
Strong analytical and problem-solving skills using root cause analysis and CAPA development
Effective delegation, organization, and motivational abilities
Ability to establish positive working relationships across departments
Clear and effective communicator in English, both written and verbal
Director, Clinical Quality Assurance
Quality manager job in Raleigh, NC
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Director, Clinical Quality Assurance
The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).
Essential Functions
* Independently conduct audits
* Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
* Facilitate Sponsor health authority inspections of global clinical facilities and study sites
* Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs
* Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
* May be responsible for direct people management including goal setting, performance management, development, and engagement.
Requirements
* Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area.
* 5+ years of experience in GCP auditing.
* Substantial experience in inspection management.
* Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
* Demonstrated ability to operate and influence decision-making processes
* Effective communication skills
* Successful track record of supervising employees and managing cross-cultural differences
* Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
* Knowledge of data integrity controls and systems quality for clinical area
* Strong analytical skills and report writing skills
* Experience with GxP systems including computer system validation and associated regulations, recommended.
* Ability to Travel (approximately 20%)
* Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.
Eisai Salary Transparency Language:
The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ***********************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyManager, Supplier Quality
Quality manager job in Parkton, NC
The Manager, Supplier Quality and Material Control ensures supplied materials meet company standards through a combination of auditing suppliers' quality systems, inspecting, and analyzes quality data, and collaborative problem-solving with suppliers and internal teams to resolve issues while implementing continuous improvement initiatives. The Manager is responsible for the inspection and release of all Good Manufacturing Practice (GMP) consumables, raw materials, and labeling manufactured product, in addition to the release of manufacturing utilities, rooms, and equipment used in manufacturing processes and maintenance of the QA retention program. This role interacts with regulatory agencies during compliance inspections, manages supplier change notifications, deviations, corrective and preventive actions (CAPAs), and change controls while partnering with engineers, management and room owners. Additionally, the Manager provides leadership to quality specialists and ensures the team is position to successfully support a 24/7 manufacturing facility.
Company Overview
At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.
From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you'll find a home here where your efforts directly improve patients' lives. Together, let's shape the future of healthcare.
Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: ***************************************************
Job Description
What You'll Do:
* Manages a team of quality specialists and determines priorities to ensure successful completion of projects and tasks
* Problem solves on supplier change notifications and deviations to determine effective solutions and root causes
* Coordinates the Vendor Change Notification Committee
* Approves all Raw Material and Consumable Item Specifications
* Assures Quality Management System (QMS) records are on time and creates proactive measures to assure QMS effectiveness
* Serves as the QA point of contact for Warehouse, Planning, and QC Raw Material escalations
* Reviews and approves relevant Material Control, Warehouse, QC Raw Material, standard operating procedures (SOPs) and STMs
* Supports client and regulatory inspections and serves as the subject matter expert (SME) for deviations, CAPAs and change controls, as needed
* Evaluates direct reports performance and addresses gaps appropriately while partnering with HR, as needed
* Provides metric and key performance indicators (KPIs) updates to the QMR lead
* Provides Quality assessments for materials related deviations, lab investigation and change controls
* Administers company policies such as time off, shift work, and inclement weather that directly impact employees
* Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
* Coaches and guides direct reports to foster professional development
* Participates in the recruitment process and retention strategies to attract and retain talent, as needed
* Performs other duties, as assigned
Minimum Requirements:
* Master's degree in quality, business management or other related field with 5+ years of experience; or
* Bachelor's degree in quality, business management or other related field with 7+ years of experience; or
* 2-5 years of people management experience
* Prior experience working in a CDMO
* #LI-Onsite
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_*****************).
Auto-ApplyCustomer Quality Program Manager (CQM) - Onsite
Quality manager job in Wilson, NC
Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of "U.S. Person" go here. **********************************************************************************************
Security Clearance:
None/Not Required
The Fire Protection business unit at Collins Aerospace is seeking a Customer Quality Program Manager (CQM). The CQM acts as the primary customer point of contact for quality and is focused on improving customer satisfaction through quality improvement initiatives. The CQM serves as the customer's voice throughout the organization, working alongside program management to lead a cross functional team in the resolution of known issues and drive preventative actions to reduce quality escapes.
This position is in a multi-disciplinary team environment and will require one who thrives on tackling challenges. The position relies on the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate solutions. A successful candidate will have some technical knowledge of manufacturing processes and experience with requirements compliance. Familiarity with purchase/sales order logistics is also desired. Heavy customer interaction will be required in this role to develop and maintain a collaborative rapport.
What You Will Do:
* Accountable for root cause corrective action investigations for nonconformance escapes with a cross functional team including members from product quality, manufacturing engineering, design engineering, operations, etc.
* Performs escape management procedures for disclosure of nonconforming hardware
* Leads customer audits/assessments as required
* Manages customer satisfaction metrics and develops plans to recover and maintain goals
* Review customer quality requirements to ensure compliance with requirements, objectives, and/or contracts
* Identifies and manages risk in product development primarily utilizing and driving PPAP core elements (e.g. PFMEA, MSA, Process Flow and Control Plans, etc.)
Qualifications You Must Have:
* Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 8 years prior relevant experience or an Advanced Degree in a related field
* In-depth knowledge of Quality Management System(s) and Root Cause Analysis tools.
* Experienced and comfortable with customer-facing responsibilities
Qualifications You Must Have:
* 5+ years in Aerospace with solid knowledge of Quality Assurance in production / manufacturing and new product development.
* FAA, EASA and other regulatory authority knowledge with PMR / MRB, Corrective action methodology experience is desired.
* Certified in the appropriate ASQ Body of Knowledge (CQE, CQA, CRE, CPA)
What We Offer:
Some of our competitive benefits package includes:
* Medical, dental, and vision insurance
* Three weeks of vacation for newly hired employees
* Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option
* Tuition reimbursement program
* Student Loan Repayment Program
* Life insurance and disability coverage
* Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection
* Birth, adoption, parental leave benefits
* Ovia Health, fertility, and family planning
* Adoption Assistance
* Autism Benefit
* Employee Assistance Plan, including up to 10 free counseling sessions
* Healthy You Incentives, wellness rewards program
* Doctor on Demand, virtual doctor visits
* Bright Horizons, child and elder care services
* Teladoc Medical Experts, second opinion program
* This position may be eligible for relocation
* And more!
Learn More and Apply Now!
Collins Aerospace, a RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market.
Our Avionics team advances flight deck solutions, airborne communications, vision systems, sensors and fire protection for commercial and military customers around the world. That means we're helping people reach their destination safely and keeping pilots, passengers, flight crews, airlines, airports and military personnel connected and informed. And we're providing industry-leading fire protection and safety systems that our customers can count on when it matters most. Are you ready to learn from the most knowledgeable experts in the industry, develop the technologies of tomorrow and reach new heights in your career? Join our Avionics team today.
WE ARE REDEFINING AEROSPACE.
* Please consider the following role type definitions as you apply for this role.
Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.
Regardless of your role type, collaboration and innovation are critical to our business and all employees will have access to digital tools so they can work with colleagues around the world - and access to Collins sites when their work requires in-person meetings.
At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again.
Apply now and be part of the team that's redefining aerospace, every day.
As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.
The salary range for this role is 101,000 USD - 203,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.
Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.
Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.
This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.
RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.
RTX 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, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
Privacy Policy and Terms:
Click on this link to read the Policy and Terms
Auto-ApplyManager Quality Control
Quality manager job in Raleigh, NC
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives.
The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing.
Job Description
ESSENTIAL FUNCTIONS:
Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines.
Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications.
Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements.
Maintain accurate records of all QC activities, including test results, deviations, and corrective actions.
Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality.
Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
Prepare for and participate in internal and external audits, including regulatory inspections.
Oversee calibration, validation, and maintenance of laboratory instruments.
Provides subject matter assistance for LIMS, methods, testing, and validation.
Manages QC testing group to achieve compliant testing in a timely manner.
Manages Lab investigations and OOSs including remediation of potential compliance concerns.
Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement.
Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation.
Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions.
Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations.
Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades.
Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory.
Ensures key turnaround timelines for customer service and compliance requirements are achieved.
Performs as a subject matter expert during customer and regulatory audits.
Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Develops and coaches to build talent.
Participate in a 5S Workplace System to ensure good housekeeping and organization.
Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
Effectively trains others in a positive manner.
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
Education:
B.S. /B.A. in Physical Science required.
Master's Degree preferred.
Experience:
10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements
Preferred Skills/Qualifications:
Other Skills/Competencies:
Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories
Experience with testing API or Pharma products
Experience leading a group of up to 20 people with 24/7 shift operations
Excellent written and verbal communication and leadership skills
Ability to work in and promote a team environment
Working knowledge of Six Sigma and/or Lean manufacturing tools
Sense of urgency.
Action oriented/drives for results
Excellent communication and interpersonal skills
Team orientation/strong team player
Ability to coach, mentor and teach
Excellent decision making, problem solving and analytical skills
Strong managerial courage
Ability to influence change at all levels of the organization
Detail-oriented with the ability to work under tight deadlines
Excellent conflict management skills
Builds positive relationships with others
Excellent time management and prioritization skills
Excellent technical writing skills
LIMS experience preferred
Knows the difference between managing and leading and when to apply each
Command Skills, Action Oriented, Conflict Management, Customer Focus,
Problem Solving, Priority Setting, Written Communication,
RELATIONSHIP WITH OTHERS/ SCOPE:
Reports to Site Quality Director
Work is performed without appreciable direction
Develops strategic objectives for group managed
Exercises considerable latitude in determining technical objectives of assignment
Completed work is reviewed for desired results from a relatively long-term perspective
Bias toward change, management of change, and achievement of results
Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits
Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S.
This position has several direct reports
WORKING CONDITIONS:
60% normal office and meeting room conditions.
40% Laboratory and Plant environment including exposure to raw materials and finished products.
Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
Some off shift and weekend work can be expected; travel requirements are minimal
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. 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.
Auto-ApplyConstruction Quality Control Manager
Quality manager job in Jacksonville, NC
We, at RQ Construction, LLC are looking for Construction Quality Control Managers (CQCM) to join our Field Operations team. Project assignment is located in North Carolina and will require working on an active project on a military base. This particular opportunity is in Camp LeJeune, NC. QC Managers are responsible for planning, coordinating, and implementing a project-specific quality control program, executing its performance according to contract requirements, completing administrative documentation on time, and cultivating customer satisfaction with the client, all in alignment with RQ's Mission, Vision, and Values. Preference will be given to local candidates depending on the project location. Relocation or travel will be required, as the QC Manager role is an on-site position
The pay range for this opening is $90-$125k
* Ten (10) or more years combined experience (or equivalent) in commercial construction industry as a Superintendent, QC Manager, Project Manager, or Project Engineer required, as well as two years' experience as a QC Manager required
* A current USACE CQM for Contractors Certificate is required and RMS/QCS training is preferred (training is available)
* Specialty inspection training and licenses/certs highly desired
* LEED AP, AP+ or Green Associate (GA) Certificate preferred
* Level 1 EM 385-1-1, CRP, First Aid, OSHA 30-hour certifications required. Training can be provided
* Computer literacy (Microsoft Office, Outlook, Internet, etc.) required
* Specific software literacy (Viewpoint/Vista, RMS/QCS) preferred
RQ is headquartered in beautiful Carlsbad, CA, we are a full-service Design-Build company. We offer management of projects throughout the United States, with our field operations' team members who work on location for each of our projects. We specialize in fast-track projects in new commercial construction for both public and private clients, with a primary focus in the Department of Defense market.
COMPANY PROFILE: Since 1996, RQC, LLC. has been a leading player in Southern California's robust commercial and governmental Design-Build economy. We now have a national presence with current projects approaching $1B, spanning coast to coast. RQC, LLC is a full service contracting and design firm that specializes in Design/Build projects for both public and private clients, with a primary focus on the Department of Defense. Our mission is "to provide our customers the best built environment while being the first choice of all stakeholders."
The firm offers a variety of services including construction, architectural design, trade services, virtual design and construction, and LEED/sustainable design management for projects ranging from $25M to over $250M. RQ's experience includes projects throughout the U.S., as well as internationally at U.S. Naval Base Guantanamo Bay, Cuba and Puerto Rico. The success of this company has been built on three pillars: Quality, Integrity, and Leadership. Our employees work hard as a team, thrive on innovation and remain committed to being the first choice of our clients as well as all other stakeholders. In return we offer an excellent work environment, very competitive compensation, and an outstanding benefits package.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, creed, gender (including gender identity and gender expression), religion (all aspects of religious beliefs, observance or practice, including religious dress or grooming practices) marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition (including cancer or a record or history of cancer, and genetic characteristics), sex (including pregnancy, childbirth, breastfeeding or related medical condition), genetic information, sexual orientation, veteran status, or any other basis or status protected by federal, state, or local law or ordinance or regulation.
All candidates considered for hire must provide evidence of identity and U.S. work authorization at the time of hire. Additionally, all candidates must successfully pass a drug screening and commercial criminal background check, including a stricter Department of Defense background check, for access to job site at military base (if applicable for position being hired for).
Submit your resume for future Manufacturing and Quality roles located in RTP, NC
Quality manager job in Durham, NC
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Beam is preparing to open a state-of-the-art Manufacturing facility located on Davis Drive in RTP, NC and will be looking for Manufacturing and Quality professionals to join our team! Please submit your resume here to be considered for positions that we will be opening in Q4 2022 and throughout 2023. We are looking for fearless innovators who are passionate about helping patients and looking to join a collaborative environment where you will be able to have a direct impact on getting our facility up and running.
Manager, Supplier Quality
Quality manager job in Parkton, NC
The Manager, Supplier Quality and Material Control ensures supplied materials meet company standards through a combination of auditing suppliers' quality systems, inspecting, and analyzes quality data, and collaborative problem-solving with suppliers and internal teams to resolve issues while implementing continuous improvement initiatives. The Manager is responsible for the inspection and release of all Good Manufacturing Practice (GMP) consumables, raw materials, and labeling manufactured product, in addition to the release of manufacturing utilities, rooms, and equipment used in manufacturing processes and maintenance of the QA retention program. This role interacts with regulatory agencies during compliance inspections, manages supplier change notifications, deviations, corrective and preventive actions (CAPAs), and change controls while partnering with engineers, management and room owners. Additionally, the Manager provides leadership to quality specialists and ensures the team is position to successfully support a 24/7 manufacturing facility.
Company Overview
At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.
From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you'll find a home here where your efforts directly improve patients' lives. Together, let's shape the future of healthcare.
Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: ***************************************************
Job Description
What You'll Do:
Manages a team of quality specialists and determines priorities to ensure successful completion of projects and tasks
Problem solves on supplier change notifications and deviations to determine effective solutions and root causes
Coordinates the Vendor Change Notification Committee
Approves all Raw Material and Consumable Item Specifications
Assures Quality Management System (QMS) records are on time and creates proactive measures to assure QMS effectiveness
Serves as the QA point of contact for Warehouse, Planning, and QC Raw Material escalations
Reviews and approves relevant Material Control, Warehouse, QC Raw Material, standard operating procedures (SOPs) and STMs
Supports client and regulatory inspections and serves as the subject matter expert (SME) for deviations, CAPAs and change controls, as needed
Evaluates direct reports performance and addresses gaps appropriately while partnering with HR, as needed
Provides metric and key performance indicators (KPIs) updates to the QMR lead
Provides Quality assessments for materials related deviations, lab investigation and change controls
Administers company policies such as time off, shift work, and inclement weather that directly impact employees
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
Coaches and guides direct reports to foster professional development
Participates in the recruitment process and retention strategies to attract and retain talent, as needed
Performs other duties, as assigned
Minimum Requirements:
Master's degree in quality, business management or other related field with 5+ years of experience; or
Bachelor's degree in quality, business management or other related field with 7+ years of experience; or
2-5 years of people management experience
Prior experience working in a CDMO
*#LI-Onsite
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_*****************).
Auto-ApplyQuality Control Manager
Quality manager job in Clayton, NC
The Quality Control Manager is responsible for planning, coordinating and developing the project specific Quality Assurance/Quality Control plan that incorporates policies and procedures necessary to deliver the project fully compliant with the contract terms of the project.
Responsibilities
* Partner with the project team to understand, plan, and implement the contract drawings and specifications
* Collaborate with the owner, design team, and contractors to ensure quality and timeliness of project construction and completion
* Implement and manage the "Three Phases of Control" Quality Control Plan
* Schedule and conduct quality control meetings - Preparatory, Initial Phase, Follow-up
* Control documents related to quality control functions
* Establish testing procedures in accordance with contract specifications
* Manage inspections process
* Coordinate third party testing agents and interface with the Owner's representatives as required
* Closely track and maintain a project deficiency log
* Manage the punch list process
* Oversee project closeout deliverable process-training, O&Ms
* Confer directly with the executive management team
* Encourage, lead, and/or participate in staff training and development
Basic Qualifications
* Undergraduate degree in a construction or related discipline or relevant experience
* Minimum 5-8+ years verifiable construction quality control and/or inspection experience
* Takes initiative and personal responsibility to always deliver value and excellence
* Uses expertise to create a vision and aligns the team to deliver/achieve desired outcomes
* A track record of establishing/contributing to creative strategic solutions
* Ability to communicate effectively with, persuade, and gain "buy-in" from, a broad range of stakeholders (leadership team, Business Unit Leader, direct reports, clients, trade partners, and third party providers)
* Alignment to BE&K standards, self-motivated, results oriented, adaptable, team player, accountable, ethical, innovative, resilient, builds relationships, builds people/teams and followership, sets direction and executes
Preferred Qualifications
* Experience in large scale Bio-Pharma construction projects
* Prior experience developing and managing Quality Control Plans
*
Physical Requirements:
* Ability to perform physical activities such as climbing, lifting, balancing, walking, and handling materials.
* Must be able to work in various weather conditions, including extreme heat and cold.
* Capable of standing and walking for extended periods.
* Ability to lift and carry up to 50 pounds.
*
Equal Employment Opportunity Statement:
BE&K Building Group is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.
Quality Control Manager
Quality manager job in Charlotte, NC
GARNEY CONSTRUCTION A Quality Control Manager position in Charlotte, NC is available at Garney Construction. Join our Garney team to manage and support project Quality Management Specialists, ensuring each project is successful. The Quality Control Manager is responsible for the implementation, management, and execution of Quality Management Programs for Federal contracting projects.
WHAT YOU WILL BE DOING
* Develop and implement project Quality Management Systems to ensure compliance with contract quality standards
* Review project CPM schedule to anticipate and request timely submittals
* Review project schedules and prepare Government meeting notices to support schedules
* Conduct weekly Quality Control meetings
* Perform/supervise quality inspections as needed by the project or Project Manager
* Provide effective and efficient communication with the Federal Government personnel
* Promote Garney's safety programs and procedures to promote a safe working environment
WHAT WE ARE LOOKING FOR
* 10 years of construction experience, 3 years being Construction Quality Manager experience
* Bachelor's Degree in Engineering, Construction Management, or related field
* Current USACOE Construction Quality Management for Contractors Certification
* EM 385 40 hour and OSHA 30-hour certifications
LET'S TALK THE PERKS!
* Employee Stock Ownership Plan (ESOP)
* 401K Retirement plan
* Health, dental, vision and life insurance
* Flexible Spending Account (FSA) / Health Savings Account (HSA)
* Long-term disability
* Wellness program
* Employee Assistance Plan
* Holidays and PTO
* Bonus program
CONTACT US
If you have questions about the position, please contact Patrick Duque at ************************ . Please include resumes, references, job lists, and any other relevant documentation.
Garney Construction and its subsidiaries are committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Garney Construction is a background screening, drug-free workplace.
Agency Disclaimer: All vendors must have a signed Garney Construction Agreement, authorized by the Executive Team, to receive payment for any placement. Verbal or written commitments made by anyone other than a member of the Executive Team will not be considered binding. Any unsolicited resumes sent to Garney Construction or submitted to employees outside of the Recruiting Team will be deemed the property of Garney Construction. In such cases, Garney Construction will not be obligated to pay any placement fees.
THE BENEFITS OF WORKING AT GARNEY
Free medical, prescription, dental, and vision plans ($0 premiums)
Virtual doctor visits with no co-pay
Shares of company stock at no cost starting your first day
401(k) plan with a 3.5% match
Student loan resources
Weekly paychecks
Paid time off
8 paid holidays
Health Savings Account (HSA) with a lump sum and matching contributions
Free life insurance & disability policy
Free access to healthcare coordinators
Counseling sessions with mental health professionals at no cost
Access to consultations with legal/financial professionals at no cost
Free programs assisting with weight loss, maternity health, prescriptions for chronic conditions, and more
50% employee discount in the Garney apparel store
BUILDING SUSTAINABLE FUTURES WITH THE WORLD'S MOST PRECIOUS RESOURCES-WATER AND PEOPLE.
EEO - it's the law poster
Right to work
This organization participates in E-verify
Nearest Major Market: Charlotte
Easy ApplyQuality Control Manager
Quality manager job in Dallas, NC
ð Work Hours: 8:00 AM to 5:00 PM, Monday through Friday ð² Competitive Compensation
Make the Right Connection-Build Your Career with Dixon!
Dixon Quick Coupling, a proud division of The Dixon Group is looking for a Quality Control Manager to join our team in Dallas, North Carolina! We are seeking a dynamic leader with a strong background in manufacturing and a proven track record of implementing and leading a Quality Management System (QMS) from its early stages. The ideal candidate is a strategic, self-starting problem-solver who works collaboratively to drive improvement, reduce costs, and deliver high-quality results with precision and purpose.
About Us: The Dixon Group is a global, family-owned manufacturing company with a history of over 100 years of operation in the U.S.A. Based in Chestertown, Maryland, with distribution centers located worldwide. The company has a diverse workforce and a strong values-based culture. As an innovator in the hose coupling industry, our mission is to provide real solutions for our customers while fostering a supportive and collaborative work environment.
At The Dixon Group, we value the contributions of our Military Veterans and proudly employ our nation's heroes. Veterans are strongly encouraged to apply.
ð What You'll Do
Take full ownership of the division's Quality Management System (QMS), including creating procedures for raw material acceptance, in-process evaluation, and final product inspection.
Lead or conduct investigations and corrective actions for significant defects and customer complaints.
Promote and lead cost reduction activities to minimize waste, scrap, and rework, which will directly reduce the business unit's cost of poor quality (COPQ).
Maintain and manage quality control instruments and testing equipment.
Provide direction and mentorship to Quality Department personnel.
Ensure compliance with the QMS by providing training and conducting audits.
Regularly report on program progress, investigation findings, root causes, and corrective actions to the Division Leadership Team.
ð¯ What We're Looking For
Experience: A minimum of 10 years of experience in a manufacturing or production environment, with at least 5 years in a decision-making role.
Education: Bachelor's degree in Engineering, Quality Management or Business Administration required.
QMS Implementation: Extensive experience in implementing a QMS, especially from the ground up.
Certifications: Experience in ISO certified facilities, with a strong preference for candidates with prior ISO 9001 implementation experience.
Leadership: Proven ability to lead and motivate teams, with a strong focus on project leadership.
Technical Skills: Proficient in relevant software, data analysis, critical thinking, and problem-solving.
Problem-Solving: Expertise in conducting investigations and determining root causes and corrective actions.
Communication: Excellent communication and interpersonal skills to work effectively with diverse teams.
Additional Skills: Six Sigma/Black Belt is a plus.
ð What We Offer
Medical, dental, and vision insurance for you and your family
Competitive salary
Bonus programs
401K retirement plan
Training opportunities
Tuition reimbursement
Paid vacation, PTO, and holidays
Gym reimbursements, and more!
Join us and be a part of a team that values your contributions and supports your goals!
The Dixon Group is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices and laws. Accordingly, to the fullest extent required by applicable law, The Dixon Group strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons. The Dixon Group is committed to protecting the privacy rights of its employees and job applicants to the fullest extent required by applicable law. To that end, personal information will be collected solely for those legitimate business purposes recognized by law, and then maintained in a manner consistent with all applicable laws and regulations pertaining to document retention requirements. The Dixon Group does not sell personal information to third parties, and does not share such personal information with third parties except when authorized by law to do so (e.g., in response to a lawful subpoena; mandatory tax reporting; etc.)
Quality Lead Technician
Quality manager job in Fayetteville, NC
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.
All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.
ACCOUNTABILITIES
Performs duties associated with Quality (including but not limited to): (50%)
Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements.
Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).
Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation.
In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations.
Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%)
Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%)
Maintain certification and perform all required duties of Lead Technician. (10%)
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience.
Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment.
Effective communication, organizational, and technical/problem-solving skills.
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Attend staff meetings and other team meetings as required.
Good verbal communication and customer service skills.
Ability to multi-task and work as a team player.
Innovation
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Complexity
Production environment requiring the ability to walk and stand for the entire work shift.
Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs.
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required
Desired: Associate or Bachelor's degree preferred
ADDITIONAL INFORMATION
FLSA Classification (US) - Non-Exempt
Other duties and responsibilities as assigned.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - NC - Fayetteville - Morgan
U.S. Hourly Wage Range:
$20.00 - $27.50
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - NC - Fayetteville - Morgan
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
No