QA SPECIALIST II - OPS

PCI NH Lyophilization Services of New England

QA SPECIALIST II - OPS

Bedford, NH, USA Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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 communicating release needs throughout the organization. Review and approve master batch records for the timely initiation of GxP manufacturing activities. Responsible for quality oversight and administration of the deviation/investigation and CAPA programs. Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance. Provide direction for complex investigations and CAPAs. Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs. Review, develop, and improve quality system procedures, specifications, and test methods. Review and approve CAPAs to prevent recurrence of deviations. Review and approve Change Control documentation. Track investigations and change control for timely completion; provide status reports, including quality metrics, and participate in the management review process. Establish collaborative relationships with internal and external customers to address quality and compliance matters. Monitor, identify, and propose quality process and system improvements. Lead improvement projects and communicate status to management. Serve as QA representative to cross-functional project teams such as tech transfer, process validation, and process improvement. Coordinate change control review meetings and monitor status of change controls to facilitate approvals. Perform risk assessments to comply with internal procedures and external guidelines. Provide training on department-specific procedures and systems. Interface with clients to address documentation and compliance concerns. Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable. Ensure site readiness for regulatory inspections.

QUALIFICATIONS

Required Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience and 3+ years in a QA Operations role supporting late-stage clinical and/or commercial production. 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 (21CFR Part 210, 211 & 820) and some experience with international regulations such as ICH. Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9. Preferred ASQ certification preferred. Exceptional organizational skills and attention to detail. Ability to make risk-based decisions and resolve issues with minimal guidance. Excellent interpersonal skills and strong verbal and written communication. Proficiency in MS Office including Word, Excel, Access, and Visio. Ability to work in a dynamic, fast-paced work environment. Honesty, integrity, respect, and courtesy in all interactions. Creative, independent thinking with minimal supervision. Resilient through operational and organizational change. Less than 10% travel. Potential additional hours and/or weekend work may be required. Equal Employment Opportunity Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. 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 orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose. 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. #J-18808-Ljbffr Dormont Manufacturing Co