QA Specialist II - Doc Control
PCI Pharma Services · Bedford, NH
- Level
- Specialist
- Team
- Quality
- Experience asked
- 10+ years
- Industry
- Pharma & life sciences
- Posted
- 26 days ago
The role in 30 seconds
A specialist quality role at PCI Pharma Services (pharma & life sciences) in Bedford, NH.
- They ask for
- 10+ years
- Tools it names
- CAPA, FDA / GMP, Validation (IQ/OQ/PQ), Internal audits
Read from the posting. The full description is below.
From the plant jobs report · week of October 19, 2026
Quality Engineer roles in New Hampshire: typical posted base $97k–$165k.
Median of the low and high ends of 15 live postings that list pay, out of 40 quality engineer openings in New Hampshire, read from manufacturers' own careers sites.
New Hampshire plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 39 other live quality postings in New Hampshire.
- Base pay
- Not listed in this posting
- Experience asked
- More than usual (10+ vs 5+)
Typical $97k–$165k, from 15 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 73%
- Lean 48%
- Six Sigma 45%
- Supplier quality 43%
- AS9100 40%
- ✓ FDA / GMP 38%
✓ = 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 in this kind of role. 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 in quality roles at PCI Pharma Services.
- Manufacturing Process Engineer · Process
- 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
Full description from PCI Pharma ServicesAs posted on their careers site.ShowHide
Responsibilities
- ◆Maintain Quality System Master Documents and Master Document List
- ◆Facilitates workflows in the electronic document management system and legacy paper processes.
- ◆Performs the creation, modification, and approval of Client Batch Records independently.
- ◆Issues and reconciles batch records, testing data capture sheets, lab books, equipment log books, room log books, and Quality System event documents.
- ◆Maintains Document, Material and Batch numbering logs.
- ◆Writes and develops QA SOPs with minimal oversight.
- ◆Administers the maintenance of the Record/Document filing system at designated sites.
- ◆Proofs and edits document changes including minor SOP updates, as directed.
- ◆Participate in or lead audit preparation and reconciliation. Support audit requests. Perform internal audit tasks.
- ◆Supports metrics / report generation.
- ◆Cross-trains and provides support for coverage of multiple production facilities as needed. Covers absences.
- ◆Lead continuous improvement efforts and projects across the department, or multiple departments. Provide input, propose resolutions.
- ◆Performs obsolete and administrative document workflow within Master Control.
- ◆Leads Quality System Investigation and CAPA action items
- ◆Train others in doc control processes.
- ◆Develops and implements new tools and processes for Document Control with minimal oversight.
- ◆Participate in or facilitate functional area programs.
Required
- ✓High School Diploma; and at least 10 years of industry experience with a minimum of 6 years document control experience in the Biotech, Pharmaceutical or Medical Device industries is required.
- ✓Previous Document Control and/or eQMS configuration and system management experience required.
- ✓Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210,211 and 820 and Industry best practices required.
- ✓Working knowledge of Computer System Validation and Change Control requirements.
- ✓Assist is leading large or cross-functional projects and improvement initiatives as assigned.
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.
Location: Bedford, New Hampshire
Department: Quality Assurance, Document Control
Reporting To: Supervisor, Document Control
Responsible For (Staff): No
The individual will manage, coordinate, and maintain cGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. The Document Control QA Specialist II will evaluate document needs and participate in the processing of Documents and Records, maintain databases and Quality Management System tools and supports personnel and functional areas as needed. The primary objective of the Document Control QA Specialist II will be to contribute to the maintenance and improvement of the Document Control program and its systems. The QA Doc Control group is dedicated to the continuous improvement of the Document Change Control Lifecycle and Quality Systems to meet current compliance standards and ensure proper processing and release of controlled documents.
Preferred
- +Superior professional communication skills across all levels of the organization written and verbally
- +Superior customer service.
- +Identify and lead large or cross-functional projects and improvement initiatives.
- +May support more than one production facility.
- +Expert skill level in MS Office, general computer uses and the electronic Quality Management System and associated tools.
- +Excellent professional written and verbal skills. Team oriented.
- +Excellent Organizational skills. Highly Efficient.
- +Excellent attention to detail.
- +Perform repetitive tasks with high level of detail, requiring decision making on daily tasks and improvement initiatives. Sound decision making ability required. Recommend solutions to Management for critical decisions.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future