Hiring: QA Specialist II - Doc Control Company: PCI Pharma Services Location: Bedford, NH Job Posted Time: 2026-09-12 13:51:58 Target Skills & Keywords : Microsoft Office, Quality Assurance About the job Experience: •10 years of industry experience with a minimum of 6 years document control experience in the Biotech, Pharmaceutical or Medical Device industries is required. •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. Required Skills: •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. Qualifications: •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. •Solid functional working knowledge of Computer System Validation and Change Control requirements. •Assist is leading large or cross-functional projects and improvement initiatives as assigned. •Superior professional communication skills across all levels of the organization written and verbally •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. Compensation: •At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!