PCI Pharma Services
Qa Specialist Ii - Ops
Bedford, NH, USA · Mid
Sponsorship not specifiedDetected 6 hours ago
ComplianceExcelProcess ImprovementGMPFDA RegulatoryCommunicationWritingOrganizational SkillsMicrosoft OfficeHACCPGxP
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Bridge to thousands of biopharma companies and their patients.
- Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality System review.
- This position may also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs.
Responsibilities
- Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
- Review, develop, and improve quality system procedures, specifications, and test methods
- Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
- Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
- Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
- Perform risk assessments to comply with internal procedures and external guidelines
- Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
- Our investment is in People who make an impact, drive progress and create a better tomorrow.
- Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Requirements
- Experience performing RCA, technical writing, and working with quality related investigations
- Knowledge of laboratory and production equipment and IQ/OQ/PQ
- Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
- Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
- Ability to make risk based decisions and resolve issues with minimal guidance
- Excellent interpersonal skills and the ability to communicate well orally and in writing
- Proficiency in MS Office including Word, Excel, Access and Visio
- Excellent verbal and written communication skills required
- Ability to work in a dynamic, fast paced work environment
- Creative with the ability to work with minimal supervision and balanced with independent thinking
- Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Nice to have
- ASQ certification preferred Exceptional organizational skills and attention to detail
Company info
- We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
- Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
Visa & Work Authorization
- We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.