PCI Pharma Services · 8 hours ago
Supervisor, QA Internal Operations
Bedford, NH
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company focused on life-changing therapies and global impact. The Supervisor, QA Internal Operations will lead a team responsible for providing QA oversight in the manufacturing of clinical and commercial drug products, ensuring compliance with cGMP principles and guidelines.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Oversee and provide QA support and guidance for daily cGMP manufacturing operations
Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release
Support scheduling activities by monitoring the production and visual inspection schedules and reviewing factors that may impact schedules
Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances; Assist with AQL Sampling and Inspection of Final Package Lots
Review and approval of Blue Mountain documents and work orders
Complete staff performance reviews and align personnel goals to corporate initiatives
Ensure all pertinent training is assigned to staff, and employee training is in good standing
Assist with review of master and executed raw material records and logbooks
Review of associated QC data to support facility and products
Participation in writing or revising Standard Operating Procedures, material control procedures, deviations, CAPA’s, and Quality Investigations when applicable
Support external client audits at LSNE, and regulatory inspections
Obtain gown qualification for sterile manufacturing line clears
Maintain and evaluate current processes and procedures, and look for opportunities for continuous improvement
Other duties as assigned
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
Assist QA Specialists in batch record reviews and generating CoAs
Qualification
Required
Bachelor's Degree in relevant scientific discipline
5+ years of pharmaceutical or biotech industry experience
3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production, or equivalent
ASQ certification Highly 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, and Excel
Excellent verbal and written communication skills required
Preferred
Ability to supervise and lead people in a dynamic, fast paced work environment
Honesty, integrity, respect and courtesy with all colleagues
Creative with the ability to work with minimal supervision and balanced with independent thinking
Resilient through operational and organizational change
Ability to coach, train, and mentor others
Cross functional staff, members of management, internal and external clients, members of the Quality organization
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