Qa Specialist Ii - Ops
PCI Pharma Services
Quality Assurance Specialist supporting clinical and commercial pharmaceutical manufacturing at a contract manufacturing organization in Bedford, NH. Responsible for batch record reviews, deviation management, investigations, and CAPAs to ensure GMP compliance and product quality.
Responsibilities
- Review and approve batch documentation for clinical and commercial product release per cGMP and regulatory requirements
- Oversee deviation, investigation, and CAPA programs; approve quality investigations and corrective actions
- Review, develop, and approve quality system procedures, specifications, test methods, and change control documentation
- Lead quality improvement projects and serve as QA representative on cross-functional teams
- Interface with internal and external customers on compliance matters and prepare regulatory inspection readiness
Requirements
- 5-7 years pharmaceutical or biotech industry experience; 3+ years in QA Operations role
- Bachelor's degree in relevant scientific discipline
- Root cause analysis, technical writing, and quality investigation experience
- Knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and ICH guidelines
- Proficiency with risk management tools (FMEA, HACCP, PHA) and MS Office suite
- Strong organizational skills, attention to detail, and written/verbal communication
- ASQ certification preferred
Vacancy posted 22 days ago
Similar jobs that could be interesting for youBased on the Qa Specialist Ii - Ops in Bedford, NH vacancy
- ...strategy includes building teams across our global network to pioneer and shape the future of PCI.JOB DESCRIPTION:Position Title: QA Specialist ILocation: Bedford, New HampshireDepartment: Quality AssuranceReporting To: QA Supervisor, External QAResponsible For (Staff):...SuggestedFull time
PCI Pharma Services
Bedford, NH16 hours ago - ...tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Position Title: QA Specialist II - Ops/Floor SupportLocation: Bedford, New HampshireDepartment: Quality Assurance OperationsReporting To: QA Supervisor or...SuggestedFull timeImmediate startShift work
PCI Pharma Services
Bedford, NH16 hours ago - ...tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Position Title: QA Specialist II - Document ControlLocation: Bedford, New HampshireDepartment: Quality Assurance, Document ControlReporting To: Supervisor,...SuggestedFull time
PCI Pharma Services
Bedford, NH4 days ago - ...departmental staff, external clients and suppliers.TRAVEL - 10-20%Qualifications:Bachelor of Science Degree preferred with 5+ years’ in a QA GMP environment; High School diploma with 10+ years’ of progressive experience in QA GMP environment considered.Ability to articulate...SuggestedFull timeContract work
PCI Pharma Services
Bedford, NH7 hours ago - ...PCI Pharma Services seeks a QA Specialist II for Document Control in Bedford, New Hampshire to manage cGMP documentation, procedures, and records while maintaining compliance with regulatory standards. The role involves coordinating document workflows, maintaining quality...Suggested
- ...PCI Pharma Services seeks a QA Specialist II to oversee supplier qualification and compliance programs across GMP operations. The role involves conducting supplier audits, managing audit observations, tracking non-conformances, and ensuring adherence to regulatory standards...
- ...departmental staff, external clients and suppliersTRAVEL - <10% localQualifications:Bachelor of Science Degree preferred with 3+ years’ in a QA GMP environment; High School diploma with 5+ years’ of progressive experience in QA GMP environment considered.Ability to articulate...Full timeContract work
PCI Pharma Services
Bedford, NH1 day ago - ...strategy includes building teams across our global network to pioneer and shape the future of PCI.JOB DESCRIPTION:Position Title: Sr. QA Specialist - Supplier QualityLocation: Bedford, New HampshireDepartment: Quality AssuranceReporting To: QA Dir, Quality Systems &...Full timeContract work
PCI Pharma Services
Bedford, NH16 hours ago - ...QA Specialist Compliance Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across...Weekend work
- Travere Therapeutics is seeking a Senior Specialist in Quality Assurance Technical to support qualification/validation activities for solid... ...from vendors meet Travere standards. A strong background in GMP QA, QMS, and regulatory knowledge is essential for success. #J-188...Remote job
- Job Description Job Description Step into a day of precision in Manchester, NH From the first part you inspect to the last record you complete, your eye for detail keeps our products compliant and customers confident. As a Quality Visual Inspector, you’ll move between...
Temco Precision Manufacturing
Manchester, NH2 days ago $95k - $124k
Department: 107100 Quality Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success...Contract workTemporary workRemote work- ...QA Specialist I will oversee batch record reviews, lot disposition, and quality system administration for clinical and commercial pharmaceutical products. The role involves deviation management, investigation oversight, CAPA coordination, and cross-functional collaboration...
- ...Millyard Advanced Medical Products, is looking for a Quality Systems Specialist to work in a dynamic Medical Device Research and Development... ...as required to DEKA personnelPromote QMS awareness to non-QA departments throughout DEKASkills needed to be successful:2+ years...Contract workWork at office
DEKA Research & Development
Manchester, NH4 days ago $159.43k
Company Overview Check out this video and find out why our team loves to work here! ( Join Us! CDM Smith – where amazing career journeys unfold. Imagine a place committed to offering an unmatched employee experience. Where you work on projects that are meaningful...Contract workFor contractorsWork experience placementFor subcontractorH1bImmediate startFlexible hoursCDM Smith
Manchester, NH2 days ago- Merrimack Manufacturing is seeking a Quality System Specialist - CAPA to support and maintain the QMS in compliance with ISO 13485 and FDA QSR. The role focuses on coordinating CAPA, NC, change control, and QMS improvements across functions. This position requires strong...
$95k - $124k
...science and service for rare patients. Position Summary The Senior Specialist, Quality Assurance Technical, will assist the Quality team with... ...professional development and enhanced job performance. Support QA with various technical projects as needed. Education/Experience...Contract workTemporary workInterim roleRemote work- DEKA Research & Development in Manchester, NH, seeks a Quality Systems Specialist to maintain and improve the quality management system in a dynamic medical device R&D setting. This high visibility role reports to the Director of Quality and directly impacts quality records...
- Position Summary The Quality System Specialist - CAPA is responsible for supporting and maintaining the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements for medical device operations. This role is primarily focused on...Work at office
- Chief Quality Officer (CQO) About the Company Highly technically advanced hospital network in New England Industry Hospital & Health Care Type Non Profit Founded 1890 Employees 1001-5000 Categories Health Care Allergies Health Insurance...
- COMPANY OVERVIEW: Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. POSITION OVERVIEW: This...Work at office
Merrimack Manufacturing
Manchester, NH16 hours ago - ...the medical community, and have highly skilled staff ready to assist customers in receiving the best care possible. The Quality Specialist reviews patient charts and sales orders to ensure information, documentation, prior authorization, and patient eligibility are met...Work at office
Reliable Respiratory
Merrimack, NH16 hours ago - ...Position Summary: The Quality Control Field Specialist is responsible for overseeing and continuously improving quality standards across warehouse and field installation operations. This role owns quality control programs, inspection frameworks, reporting, and corrective...H1bWork at officeLocal area
Leaf Home
Suncook, NH16 hours ago - Start your career in quality control with ultimate flexibility! We have immediate openings for quality assurance associates to support production on short-term mandates. This role is perfect for detail-oriented individuals who are comfortable with visual checks and documentation...Hourly payTemporary workWork experience placementImmediate startShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Qa Specialist Ii - Ops. Be the first to apply!
Related searches