QA Specialist I - Compliance

PCI Pharma Services · Bedford, NH

Level: Specialist
Team: Quality
Degree: Preferred
Experience asked: 5+ years
Industry: Pharma & life sciences
Posted: 30+ days ago

The role in 30 seconds

A specialist quality role at PCI Pharma Services (pharma & life sciences) in Bedford, NH. Provide comprehensive administrative support to the Director of Quality Systems & Compliance and the Compliance team.

They ask for: 5+ years · degree preferred
Tools it names: FDA / GMP, Internal audits

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)

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 5+ 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
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?
- 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 Tech Lead, M-F 8:30 AM to 5PM · Manufacturing · Technician
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

All 25 roles at PCI Pharma Services →

Full description from PCI Pharma ServicesAs posted on their careers site.Show

Responsibilities

◆Provide comprehensive administrative support to the Director of Quality Systems & Compliance and the Compliance team.
◆Coordinate all client and internal audits by securing conference rooms, scheduling meetings, obtaining and organizing documents, and ensuring a professional and welcoming environment.
◆Order and maintain office supplies for the Compliance team, as needed.
◆Manage the Compliance spreadsheets for tracking of all client and internal audit schedules.
◆Manage the Compliance spreadsheets for tracking of all client and internal audit responses.
◆Responsible for managing the transfer of client audit report observations to the PCI audit response templates.
◆Provides support as directed by the Director of Quality Systems & Compliance and the Compliance team during FDA and other regulatory agency inspections.
◆Provide continuous improvement support as directed by the Director of Quality Systems & Compliance and the Compliance team.
◆Assist in follow up and tracking of client and internal audit commitments to assure timely closure as directed.
◆Scan, store, and maintain documentation in electronic and physical filing systems, if applicable, ensuring accuracy, completeness and accessibility.
◆Assist with other duties as assigned.

Required

✓Associates degree plus 5 years of relevant experience or HS diploma and 10 years relevant experience
✓Minimum of 5 years of experience in office coordination, administrative support, or documentation management, preferably in a regulated industry such as pharmaceuticals or biotechnology
✓Intermediate
✓Ability to perform computer tasks and knowledge of various computer programs.
✓Excellent communication skills, both written and verbal, with the ability to interact professionally with internal and external stakeholders at all levels.
✓Ability to follow instructions and respond to management direction.
✓Ability to work independently and/or as part of a team.
✓Ability to display excellent time management skills.
✓Ability to work in a dynamic, paced work environment.
✓Ability to communicate clearly and concisely with cross functional staff, members of management and external clients.
✓This position may require additional hours and/or weekend work.

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.

Reporting to the Director of Quality Systems & Compliance, the QA Specialist – Compliance is responsible for providing essential administrative support to the Compliance team and managing various client and internal audit documentation.

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, Excel, Access and Visio
+Excellent verbal and written communication skills required
+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