PCI Pharma Services

QA Specialist II - Operations

Bedford, NH, USA · Mid

Sponsorship not specifiedDetected 21 days ago

ComplianceExcelProcess ImprovementGMPFDA RegulatoryCommunicationWritingOrganizational SkillsMicrosoft OfficeHACCPGxP

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.

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.

Creative with the ability to work with minimal supervision and balanced with independent thinking

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
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 the ability to communicate well orally and in writing
Proficiency in MS Office including Word, Excel, Access and Visio

Together, delivering life-changing therapies.
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.
We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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.

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.

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

This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.