Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
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.
JOB DESCRIPTION:
Position Title: Sr. QA Specialist – Supplier Quality
Location: Bedford, New Hampshire
Department: Quality Assurance
Reporting To: QA Dir, Quality Systems & Compliance
Responsible For (Staff): No
This position is part of PCI’s Quality Compliance team responsible for the quality aspects of supplier quality management for suppliers that provide raw materials, components, contract test labs and services for GMP operations. The position is responsible to ensure all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for compliance relative to the overall Supplier Qualification Program by performing supplier audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports
- Responsible for follow up and tracking of supplier audit observations to assure timely closure
- Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling
- Responsible for reviewing all audit responses to assure non-recurrence of deficiencies
- Maintain, trend, analyze and report quality metrics as it relates to supplier audits and performance
- Drafting, review and management of supplier quality assurance agreements (QAA’s) and non-disclosure agreements
- Provide support for Quality Council meetings
- Provides support during FDA and other regulatory agency inspections
- Complete assignments and works independently without appreciable direction
- Writes and revises QA Standard Operating Procedures (SOP)
- Support continuous improvement initiatives
- Performs other duties as assigned.
QUALIFICATIONS:
Required:
- Bachelor of Science Degree preferred with 15+ years’ in a QA GMP environment; alternatively, Master’s Degree with 10+ years’ experience in a QA GMP environment. (High School diploma with 20+ years’ of progressive experience in QA GMP environment).
- Exceptional organizational skills
- 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
- Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is a must
- Thorough knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) Guidance’s, and ICH is required; EMEA and other agency regulations
Preferred:
- Auditing certification preferred (i.e., ASQ, CQA or similar)
- Experience working with cross-functional teams, including giving training and/or presentations to large groups
- Detail oriented and a results driven team player
- Ability to work 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
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) 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: 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.
Skills Required
- Bachelor of Science Degree
- 15+ years in a QA GMP environment or Master’s Degree with 10+ years experience
- Expertise in FDA regulations
- Proficiency in MS Office
- Auditing certification preferred (i.e., ASQ, CQA or similar)
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
