Exciting opportunity to join a growing pharma organization and grow your career in quality!
Job Detail
Job Description
Position Summary
Under the direction of the QA Document Control Supervisor, the QA Systems Associate – Document Control will be responsible for searching, reviewing, comparing, and verifying data using Excel, MasterControl, and SAP OpenText. This role involves working closely with the IT Validation team for data review and migration processes. The individual should have a working knowledge of the document management life cycle.
Overall Job Responsibilities
Financial (5% of time)
- Maintain quality system controls to ensure compliance.
- Take steps to reduce wastage and losses in the process.
Operational Excellence (50% of time)
- Act as a liaison between QADC and the IT Validation Team for the DMS validation project:
- Review Excel data against set criteria.
- Search and edit in MasterControl.
- Perform document reviews against set criteria/protocol.
- Execute activities within the Document Management Systems compliantly.
- Perform other duties as required.
Stakeholder Management (30% of time)
- Support all cross-functional teams within the site for document control needs.
- Maintain documents per guidelines to ensure quick retrieval.
Innovation (15% of time)
- Assist in implementing systems to enhance the document management process and daily operations.
Knowledge, Skills, and Abilities
Education
- Associate's degree in a scientific discipline or a closely related technical field preferred.
- High School Diploma required.
Experience
- 2-5 years of experience in the pharmaceutical and FDA/GMP industry preferred.
- Previous quality experience preferred.
- Any IT quality certifications are a plus.
Knowledge and Skills
- Excellent computer skills, particularly in Excel and Word.
- Knowledge of MasterControl, Documentum, SAP OpenText, and Trackwise is a plus.
- Proactive, results-oriented, with strong attention to detail.
- Self-starter with a good work ethic, able to work independently with minimal supervision or as part of a team.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Excellent verbal and written communication skills. Must be able to read, write, and speak English.
Leadership/Managerial Attributes
- Strong organizational, troubleshooting, and problem-solving skills.
- Ability to analyze details and make structured decisions daily.
- Strong interpersonal skills to interact professionally with all levels of personnel.
Other Requirements
- Good communication skills.
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