Hiring: QA Specialist, I Company: PCI Pharma Services Location: Bedford, NH Job Posted Time: 2026-09-17 00:51:53 Target Skills & Keywords : Microsoft Excel, Microsoft Office, Quality Assurance, Risk Management, Visio About the job Experience: •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 •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 Required Skills: •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 batch record review in support of business needs including maintaining batch status and communicate release needs throughout the organization •Review and approve master batch records for the timely initiation of GxP manufacturing activities •Lead and oversee 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, and CAPAs Qualifications: •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 •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 •Exceptional organizational skills and attention to detail •Demonstrated capacity 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 •Demonstrated capacity to work in a dynamic, fast-paced work environment •Honesty, integrity, respect and courtesy with all colleagues Compensation: •At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!