Company: Novozen Health Care
Location: Raleigh, North Carolina
Employment Type: Contract (6 Months)
Job ResponsibilitiesProvide Quality oversight of Commissioning, Qualification, and Validation (CQV) programs within regulated pharmaceutical or medical device manufacturing environments.
Author, review, and approve User Requirements Specifications (URS), commissioning plans, and IQ/OQ/PQ protocols and reports.
Provide risk-based Quality oversight for equipment qualification, Computerized System Validation (CSV), cleaning validation, and process validation activities.
Review Annual Product Quality Reviews (APQRs) and maintain site Validation Master Plans (VMPs).
Serve as a Quality Validation SME for deviations, CAPAs, and change controls related to qualification, validation, facilities, and utilities.
Collaborate with MSAT, Validation, Engineering, Manufacturing, Metrology/Maintenance, and QC teams during FAT, SAT, and facility start-up activities.
Support internal and external audits, client audits, and regulatory inspections as a Validation Quality SME.
Monitor validation packages, track program performance, identify compliance risks, and report KPIs to leadership.
Review quality records, SOPs, and manufacturing documentation to ensure accuracy, completeness, and cGMP compliance.
Identify opportunities for continuous improvement and provide guidance and training to junior QA Validation specialists and cross-functional teams.
Bachelor's degree in Engineering (Biomedical, Chemical, or Mechanical), Biology, Chemistry, Pharmacy, or a related scientific discipline.
Minimum of 7 years of experience in the pharmaceutical or medical device industry.
Minimum of 5 years of hands-on Engineering, Validation, or CQV experience.
Strong knowledge of 21 CFR Parts 210/211, 600, and 820 (QMSR), ISO 13485, ISO 9001, and ICH Q9/Q10.
Demonstrated experience reviewing and approving qualification and validation protocols, reports, and supporting documentation.
Experience supporting deviations, CAPAs, change controls, and regulatory inspection readiness.
Proficiency with electronic quality management systems such as Documentum, Veeva Vault, and TrackWise.
Strong analytical, troubleshooting, problem-solving, communication, and organizational skills.
Ability to collaborate effectively across multiple departments and organizational levels.
Ability to provide managerial references is required.
Anticipated hourly pay range $40 $45 per hour on W-2.
BenefitsEmployees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.
Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.
...TitleMobile Device Management (MDM) AdministratorCompany OverviewA leading professional services organization is seeking a MDM Administrator to support its growing global workforce. The organization is known for delivering high-impact services in a fast-paced, technology...
...Wheeling is looking for urgent, detail-oriented, and high-energy Food Runners to join our front-of-house service team. Famous across Chicagoland... ...massive portions, and high-volume dining, our kitchen line moves fast, and our food runners are the crucial bridge between the kitchen...
...bringing Starbird Chicken to Colorado. Starbird was founded in 2016, and our vision from the beginning was to re-invent the traditional fast food experience. We are passionate about quality food, hospitality, and creating growth opportunities. Our restaurants are...
...enterprise data platform, and we need a senior researcher who can close the loop between user... ...equivalent experience ~4+ years of CX/UX research experience, planning and running... ...to office location, role, skill set, and level of experience. Accenture Federal Services...
...bigger than yourself? Would you like to give back to your community? Are you interested in helping a child learn and participate in sports that they otherwise may not have the opportunity to try? This may be your opportunity! The YMCA of Northwest Florida is seeking...