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Sr. QA Specialist - Supplier Quality

PCI Pharma Services · Bedford, NH

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Level
Senior
Team
Quality
Degree
Preferred
Experience asked
15+ years
Industry
Pharma & life sciences
Posted
30+ days ago

The role in 30 seconds

A senior quality role at PCI Pharma Services (pharma & life sciences) in Bedford, NH. 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.

They ask for
15+ years · degree preferred
Tools it names
FDA / GMP, Supplier quality
Openings
2 with this title at this site

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

Typical $97k–$165k, from 15 postings that list pay.

Experience asked
More than usual (15+ vs 5+)

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.

It asks for 15+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

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. 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. 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. 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?
    • How did you land the job? What stood out in your interviews?
  4. 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. 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.

All 25 roles at PCI Pharma Services →
Full description from PCI Pharma ServicesAs posted on their careers site.Show

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.

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
Show full description ↓

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.

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.

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

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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