What are the responsibilities and job description for the Quality Assurance Specialist position at GForce Life Sciences?
Quality Assurance Specialist II
8-month Contract
Onsite in Scarborough, ME
Must be able to work on a W2
Requirements
- Review production batch records (DHRs) for accuracy and completeness to approve intermediate and finished goods; report and ensure resolution of deviations prior to approval
- Conduct spot-check inspections and audits of production operations
- Participate in the internal audit program
- Write, review, and approve Standard Operating Procedures (SOPs) as needed
- Assist with and author validations and test protocols as necessary
- Test complaint and stability samples; report results outside of acceptance limits
- Initiate and author Deviations and Quality Incidents (QI)
- Provide backup support to other Quality Specialists
- Administer or support calibration, document control, deviation, Quality Incident, CAPA, quality records, and sample retention programs as assigned
- Organize and administer long-term stability programs as assigned
- Train Quality Assurance Technicians and Specialists as needed
- Manage change control documentation, including assignment of Design History File numbers
- Compile, maintain, organize, store, and archive quality system records related to design change projects
- Ensure design change records are complete and aligned with SOPs
- Proofread product labeling prior to review and approval
- Initiate, execute, and implement labeling changes in coordination with internal and external stakeholders
- Assist with implementation of product changes and manage assigned design change projects
- Perform other duties as assigned
Qualifications
- Bachelor’s Degree in Chemistry, Biology, Life Science, or related technical field, or equivalent combination of education and experience
- Minimum three years of experience in a Quality Assurance role within manufacturing
- 3 years of experience in a Quality Assurance or similar role in the medical device industry (preferred)
- Ability to follow procedures and accurately document results
- Knowledge of inventory management, document control, and quality incident tracking systems
- Proficiency in Microsoft Excel and Word
- Understanding of manufacturing processes and ability to identify deviations from approved procedures
- Ability to read and interpret safety rules, operating instructions, and procedure manuals
- Ability to write routine reports and correspondence
- Ability to communicate effectively with groups of employees or customers
- Ability to interpret written, oral, diagram, or schedule-based instructions
- Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions
- Strong attention to detail