Full-Time

Quality Assurance Specialist 2

Document Control

PCI Pharma Services

PCI Pharma Services

1-10 employees

Pharmaceutical packaging and contract services

No salary listed

Bedford, NH, USA

In Person

On-site in Bedford, New Hampshire. Relocation not specified.

Bachelor's

Category
Biology & Biotech (1)
Required Skills
GMP
Quality Assurance (QA)

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Requirements
  • 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.
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.
Desired Qualifications
  • 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.

PCI Pharma Services offers end-to-end pharmaceutical packaging and related services, including Folding Cartons, Labels, Contract Packaging, Clinical Services, and Brand Protection. It serves as a one-stop source for healthcare product developers and manufacturers, handling carton and label production, packaging operations, clinical services, and brand protection under one roof. The company stands out with eight decades of experience, strict cGMP and ISO compliance, lean manufacturing, ongoing R&D, and comprehensive employee training, security, hygiene, and inspection practices. Its goal is to be a trusted, end-to-end packaging partner that delivers reliable, compliant, and scalable packaging solutions, so clients can focus on their core business.

Company Size

1-10

Company Stage

Debt Financing

Total Funding

$4B

Headquarters

Burlington, Canada

Founded

1971

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Simplify Jobs

Simplify's Take

What believers are saying

  • April 2026 investment exceeds $1 billion, adding capacity through 2028.
  • Bedford line began full-scale production in April 2026, reaching 33 million vials annually.
  • Bain Capital, Kohlberg, and Mubadala reinvested in July 2025, backing expansion.

What critics are saying

  • NLRB case filed February 11, 2026 alleges bad-faith bargaining with United Steelworkers Local 286.
  • Illinois civil-rights suit against PCI remained active in July 2026, adding reputational drag.
  • San Diego’s 2028 line delays revenue; execution misses would undercut the $1 billion thesis.

What makes PCI Pharma Services unique

  • PCI spans sterile fill-finish, device assembly, packaging, and development across 38 GMP facilities.
  • January 2026 acquisition of Ajinomoto Althea created San Diego prefilled-syringe scale.
  • Bedford and Rockford buildouts support autoinjectors, cartridges, and high-potent biologics.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Paid Vacation

401(k) Retirement Plan

Health Savings Account/Flexible Spending Account

Company News

Nikkei
May 20th, 2026
Atsushi Watanabe to become president of PCI Holdings

Atsushi Watanabe to become president of PCI Holdings May 20, 2026 17:59 Atsushi Watanabe: Graduated from Shinshu University's Faculty of Economics in 1986 (Showa 61). Joined Kyodo VAN (now SCSK). Became president of SCSK Serviceware in 2022 and director of Lester in April 2026. Born in Hyogo Prefecture. Aged 64. (Will become president on June 23. Current president Kensaku Morishita will become senior managing director) All articles freely readable Paid members get first month free AI trained on Nikkei online edition articles

Megaproject
Apr 29th, 2026
PCI Pharma Services makes $1B investment to scale injectable manufacturing, device assembly.

PCI Pharma Services makes $1B investment to scale injectable manufacturing, device assembly. By Pharma Manufacturing - Facilities - April 29, 2026 - 5 min Philadelphia-based PCI Pharma Services, a global contract development and manufacturing organization (CDMO), has announced a series of infrastructure investments aimed at expanding its sterile fill-finish and advanced drug delivery capabilities, as demand for injectable therapies and supply chain resilience continues to reshape the pharmaceutical industry. The investments are part of a broader commitment exceeding $1 billion across PCI's U.S. and European operations, meant to reinforce the CDMO's ability to support drug product development and manufacturing, clinical trial supply, and drug-device combination assembly from clinical stages through commercial launch. Central to the announcement is a $100 million investment at PCI's San Diego campus, where the company will install a high-speed isolator filling line for ready-to-use (RTU) prefilled syringes and cartridges. The new line, expected to be operational in the first half of 2028, will more than double the site's existing syringe and cartridge capacity, which already supports more than 45 FDA-approved products. The San Diego campus also hosts large-scale aseptic filling for prefilled syringes and cartridges, alongside specialized capabilities in oligonucleotides, peptides, complex formulations, and lyophilization for injectables such as nanoparticles, mRNA, monoclonal antibodies, proteins, and highly potent products. Chief Commercial Officer Tim Roberts told Pharma Manufacturing these investments reflect a broader shift toward injectable drug formats, driven in part by the rapid rise of GLP-1 therapies and other biologics that are increasingly administered outside traditional healthcare settings. This trend is also extending into more complex therapeutic areas, including oncology and central nervous system (CNS) disorders, making drug-device combinations more central to how therapies are developed and delivered, according to Roberts. "Now those next-generation medicines for oncology, CNS, and rare diseases no longer need to be delivered strictly by healthcare professionals," says Roberts. "That accepted technology of pens, autoinjectors, and on-body devices is now being recognized by pharma companies and payers as the forward modality of how these lifesaving medicines can be delivered in a much more patient-centric way." In parallel, PCI's Bedford, New Hampshire site is commissioning a GMP-ready isolator vial and lyophilization line capable of producing batches of up to 300,000 vials at 400 units per minute - equating to approximately 33 million units annually - following the start of full-scale production in April. The campus will also bring online a customer-dedicated high-potent sterile fill-finish line, according to the company. Both sites are also being outfitted with advanced automated visual inspection (AVI) systems for sterile fill-finish applications. According to Roberts, these systems enhance defect detection - including particulates and cosmetic issues - while enabling rapid, highly accurate inspection of both containers and drug products, helping expand capacity without compromising quality. PCI's U.S.-based AVI infrastructure includes annual accommodation for 40 million blister units, 70 million bottles, and 75 million vials. "It can do these things very quickly and very accurately," Roberts said of the AVI systems. "In investing in AVI systems to this degree, PCI is furthering its ability to have ample room without sacrificing mission-critical quality control." The company has also committed to multiple buildouts of autoinjector and drug-device combination assembly infrastructure, in partnership with leading device manufacturers, at its campuses in Philadelphia and Rockford, Illinois. These upgrades are being introduced in phases over the next six months and are designed to expand both capacity and operational scale of its clinical-through-commercial capabilities. PCI plans to add a third autoinjector assembly line in 2027, which will bring its total U.S. capacity for autoinjector and device assembly to more than 250 million units annually. The lines are designed for high-speed, flexible manufacturing, with the ability to support multiple device formats, while dedicated prefilled syringe safety device capabilities add labeling and secondary packaging options. That growth aligns with what Roberts describes as a clear shift across the development pipeline, with more clinical programs - and ultimately commercial products - moving toward delivery formats such as prefilled syringes, pens, and autoinjectors. These systems support self-administration and are also enabling more decentralized clinical trial models, reducing the need for frequent site visits and potentially improving patient participation and retention. PCI's integrated model, spanning prefilled syringe manufacturing through final device assembly and packaging, is designed to support that continuity. The company's Packaging Centers of Excellence in Philadelphia and Rockford provide capacity for both oral solid dose and injectable products, along with cold chain storage and the ability to rapidly support programs at clinical or commercial scale. Across the two sites, available capacity includes approximately 40 million blister units, 70 million bottles, and 75 million vials annually. In conjunction with expanding its manufacturing platform, PCI is also investing in dedicated Development Centers of Excellence (CoE) in Bedford, New Hampshire, and León, Spain. These centers will support a range of development activities, including lyophilization, formulation, analytical services, drug-device combination development, long-acting injectables, and ophthalmic products, according to the company. The CoEs are designed to handle both highly potent and non-potent, small-molecule and biologic modalities across vials, prefilled syringes, and cartridges. The Bedford Development CoE is expected to be operational this May, with the León site slated for June. Andy Lundin has more than 10 years of experience in business-to-business publishing producing digital content for audiences in the medical and automotive industries, among others. He currently works as Senior Editor for Pharma Manufacturing and is responsible for feature writing and production of the podcast. His prior publications include MEDQOR, a real-time healthcare business intelligence platform, and Bobit Business Media. Andy graduated from California State University-Fullerton in 2014 with a B.A. in journalism. He lives in Long Beach, California. Recent Comments

BioProcess International
Aug 15th, 2025
Building a better facility: BPI tours PCI manufacturing plant in Bedford

On the last day of June 2025's BIO conference in Boston, Massachusetts, contract development and manufacturing organization (CDMO) PCI Pharma Services bused a crowd of delegates to its manufacturing site in Bedford, New Hampshire where it hosted a tour of its 50,000 square-foot expansion.

Montgomery County
Jul 24th, 2025
PCI Pharma Services Valued at $10B

PCI Pharma Services in Northeast Philadelphia has received a multibillion-dollar investment from Bain Capital and Kohlberg, valuing the company at $10 billion. Kohlberg had previously invested in PCI, while Bain is a new investor. The investment will help PCI expand its services and geographic reach. The company currently operates 38 sites across seven countries and employs over 7,500 people.

JD Supra
Jul 16th, 2025
Healthcare & Life Sciences Private Equity Deal Tracker: Bain Capital and Kohlberg Invest in PCI Pharma

Healthcare & life sciences Private Equity deal tracker: Bain Capital and Kohlberg invest in PCI Pharma.