PCI Pharma Services
QA Specialist II - Doc Control
Bedford, NH, USA · Mid
Sponsorship not specifiedDetected 6 hours ago
ComplianceAuditingGMPFDA RegulatoryMedical DevicesCommunicationMicrosoft OfficeInternal Audit
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16Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Bridge to thousands of biopharma companies and their patients.
- Team oriented. - Excellent Organizational skills.
- Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
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.
Requirements
- 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.
- Sound decision making ability required.
- 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.
- Assist is leading large or cross-functional projects and improvement initiatives as assigned.
- 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.
Skills
- QA Specialist II - Document Control
- Bedford, New Hampshire
- Quality Assurance, Document Control
- Reporting To:
- Supervisor, Document Control
- Responsible For (Staff):
Benefits
- Cross-trains and provides support for coverage of multiple production facilities as needed.
Company info
- We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
Visa & Work Authorization
- We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.