PCI Pharma Services · 4 hours ago
QA Supervisor, External QA
Bedford, NH, USA
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company focused on life-changing therapies with a global impact. The QA Supervisor will work with various departments to ensure product quality and compliance with internal procedures and external standards, providing oversight for client-facing QA operations.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
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
Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
Responsible for quality oversight of manufacturing activities on a day to day basis and administration of the Quality investigation records and CAPA programs
Review / approve Manufacturing, QC, and other investigations in support of batch release and cGMP compliance. Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events including deviations, GxP investigations and CAPAs
Review and approve CAPAs and associated change control to prevent recurrence of deviations
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process
Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement
Perform risk assessments to comply with internal procedures and external guidelines
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
Manage assigned QA staff, providing feedback and development to enhance team capability. Provide training on department specific procedures and systems
Partner with QA staff to ensure site readiness for regulatory inspections. Assist with internal audits and supplier audits as needed
Interface with clients to address any documentation and compliance concerns
Qualification
Required
Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 5+ years of pharmaceutical or biotech industry experience
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
Preferred
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Knowledge of electronic systems including any of the following SAP, LIMS, MasterControl, Trackwise, Veeva, or electronic batch recording systems, is desirable
Microsoft Office suite knowledge and proficiency with Excel is desirable
Previous Supervisory experience ‘Preferred'
ASQ certification preferred
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase