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2 months ago
Position Overview
The Quality Assurance Specialist II, within the Infectious Disease Developed Markets business unit located in Scarborough, Maine, performs a wide variety of activities to support the Quality Management System under minimal direction.
Key Responsibilities
Quality System Management
- Review production batch records (DHRs) for accuracy and completeness to approve intermediate products for use in production. Review finished goods batch records, report deviations, and ensure resolutions prior to approval.
- Conduct spot-check inspections/audits of production operations.
- Participate in the internal audit program.
- Write, review, and approve Standard Operating Procedures (SOPs) as necessary.
- Assist with and potentially write validations/test protocols as necessary.
- Assist in testing complaint samples and stability samples, reporting results out of acceptance limits.
- Provide backup to other Quality Specialists.
- Initiate and author Deviations and Quality Incidents (QI).
- Potentially administer the calibration program.
- Potentially administer the Document Control program.
- Potentially administer the Deviation, Quality Incident, and CAPA programs.
- Organize the long-term stability program and administer the sample retention program.
- Administer the Quality Records program and act as backup to the Document Control Specialist II.
- Train new and current Quality Assurance Technicians and Specialists as needed.
- Other duties as assigned.
Change Control Management
- Change Management Documentation
- Assign Design History File numbers.
- Compile and maintain quality system records associated with design change projects, including project definitions, first-lot-to-stock, product qualification records, etc.
- Ensure records for design change projects are complete and align with SOPs.
- Manage organization, storage, and archival of documentation and records associated with design changes and labeling.
- Labeling Process Administration
- Proofread product labeling prior to team review and approval.
- Initiate, execute, and implement label changes in coordination with interdepartmental and external stakeholders.
- Change Control Execution
- Assist with the implementation of product changes in conjunction with project leads.
- Manage assigned Design Change projects, typically associated with product labeling.
Basic Qualifications
- Bachelor’s Degree in Chemistry, Biology, Life Science, or a related technical field, or an equivalent combination of education and experience.
- Minimum of three years in a Quality Assurance role for manufacturing.
Preferred Qualifications
- 3+ years of prior experience in a Quality Assurance role or a similar support role in the medical device industry.
