PCI is looking to solve the problem of maintaining the highest standards of safety, accuracy, and efficiency in a cGMP-regulated environment by hiring a Document Control Specialist to join their Quality Assurance team.
Requirements
- Experience with data processing, spreadsheets, and document management systems.
- Proficiency in MS Office Suite.
- Strong organizational skills with keen attention to detail.
- Experience with cGMP requirements.
- Ability to manage multiple priorities in a dynamic environment.
- Familiarity with pharmaceutical industry regulations and standards.
- Knowledge of quality processes and continuous improvement initiatives.
Responsibilities
- Manage and maintain controlled documents, procedures, and records in compliance with cGMP requirements.
- Support document lifecycle management: review, approve, issue, distribute, archive, and obsolete records.
- Facilitate client batch record creation, modifications, and approvals.
- Maintain databases, numbering logs, and satellite areas for paper-based record systems.
- Issue and archive batch records, testing sheets, lab/room/equipment logbooks, and QA event documentation.
- Assist with audits, SOP reviews, and preparation of documentation for inspections.
- Draft and edit SOPs, ensuring clarity and compliance.
Other
- High School Diploma/Associate’s degree with 8+ years of cGMP experience, or Bachelor’s degree with 1–5 years of prior GMP experience.
- Ability to lift up to 20 lbs., bend, squat, climb, and reach as needed.
- Comfortable presenting or training in group settings.
- Team player who thrives on collaboration and continuous improvement.
- Clear and professional communication skills (written and verbal).
