QA Specialist II - Supplier Quality
PCI Pharma Services · Bedford, NH
- Level
- Specialist
- Team
- Quality
- Travel
- 20%
- Degree
- Preferred
- Experience asked
- 5+ years
- Industry
- Pharma & life sciences
- Posted
- 17 days ago
The role in 30 seconds
A specialist quality role at PCI Pharma Services (pharma & life sciences) in Bedford, NH.
- They ask for
- 5+ years · degree preferred
- Tools it names
- FDA / GMP, Supplier quality
- Day to day
- about 20% travel
Read from the posting. The full description is below.
How this role compares
Against 37 other live quality postings in New Hampshire.
- Base pay
- Not listed in this posting
- Experience asked
- Typical (5+ years)
Typical $97k–$165k, from 15 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 71%
- Lean 47%
- Six Sigma 45%
- ✓ Supplier quality 42%
- AS9100 39%
- ✓ FDA / GMP 37%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at PCI Pharma Services
We found 2 people at this company and state: 2 on the team. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to Jill → (free) - 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- The posting says about 20% travel. Between which sites?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: PCI Pharma Services in Bedford
24 other open roles at this site · 2 people we found on the quality team.
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- Manufacturing Technician III/Lead M-F 4PM to 12:30 AM · Manufacturing · Technician
- Manufacturing Technician I/II/III M-F 4PM - 12:30 AM · Manufacturing · Technician
- Manufacturing Technician I/II/III · Manufacturing · Technician
- Sr. Continuous Improvement Manager · Lean / CI · Manager
Full description from PCI Pharma ServicesAs posted on their careers site.ShowHide
Responsibilities
- ◆Responsible for compliance relative to the overall Supplier Qualification Program by scheduling and conducting 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 ensure timely closure.
- ◆Monitor, communicate, and reconcile supplier change notifications, supplier non-conformances, and complaints.
- ◆Responsible for reviewing all audit responses to assure non-recurrence of deficiencies.
- ◆Drafting, review, and management of supplier quality assurance agreements and non-disclosure agreements.
- ◆Collaborate with Corporate Supplier Quality team members; align on Supplier Qualification program initiatives, report status of site-specific Supplier Qualification actions.
- ◆Support Supplier Risk Assessments.
- ◆Support Annual Product Quality Review’s.
- ◆Support Quality System Events impacting the Supplier Quality program.
- ◆Request, reconcile, and file Supplier Qualification documentation from vendors.
- ◆Track and maintain KPI metrics for the Supplier Qualification program.
- ◆Writes and revises Standard Operating Procedures (SOP).
- ◆Support continuous improvement initiatives.
- ◆Ability to travel 10-20%
- ◆Performs other duties as assigned.
Qualifications
- ✓Bachelor of Science Degree preferred with 5+ years’ in a QA GMP environment; High School diploma with 10+ years’ of progressive experience in QA GMP environment considered.
- ✓Ability to articulate and comprehend industry related technical subject matter.
- ✓Exceptional organizational skills.
- ✓Excellent interpersonal skills and the ability to communicate well orally and in writing.
- ✓Ability to work in a dynamic, fast-paced environment.
- ✓Proficiency in MS Office including Word, Excel, Access and Visio.
- ✓Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is preferred.
- ✓Knowledge of regulatory guidance (i.e., FDA 21CFR Part 210, 211 & 820; EMA), and ICH is preferred.
- ✓Experience working with cross-functional teams.
- ✓Detail oriented and a results-driven team player.
- ✓Honesty, integrity, respect and courtesy with all colleagues.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Show full description ↓Show less ↑
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.
Summary of Objective
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 for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.
Special Demands
- •Is assigned tasks and duties regularly from direct manager and senior team members.
- •Ability to work independently with moderate support from direct manager.
- •Ability to maintain organization of assigned tasks and meet deadlines.
- •Ability to think strategically and tactically.
- •Frequent reading, writing, and verbal communication.
- •Able to work in a highly complex and regulated environment.
- •Able to translate ideas to actual concepts and processes.
Work Environment
- •Interacts with all departmental staff, external clients and suppliers.
- •TRAVEL – 10-20%