QA Specialist II

QA Specialist II

Location: 10 Southgate Road, Scarborough, Maine 04074

Duration: 12 Months | 100% Onsite

Pay Range: $30–$33 per hour (W2)

Position Summary: The Quality Assurance Specialist II position is part of the Infectious Disease Business Unit located in Scarborough, Maine. Under minimal supervision, this role performs a broad range of responsibilities to support the Quality Management System. Duties may evolve based on business needs, and this job description may be reviewed and updated periodically.

• Review production batch records (DHRs) for accuracy and completeness; approve intermediate products for production use and review finished goods batch records. Report deviations and ensure they are resolved prior to approval.
• Perform spot-check inspections and audits of production operations.
• Participate in internal audit activities.
• Write, review, and approve SOPs as required.
• Assist with development and review of validations and test protocols.
• Support testing of complaint and stability samples, reporting any results outside acceptance criteria.
• Provide backup support to other Quality Specialists.
• Initiate and author Deviations and Quality Incidents (QIs).
• Potentially administer programs such as calibration, document control, deviation/QI/CAPA, long-term stability, and sample retention.
• Maintain and administer Quality Records and support Document Control functions.
• Train new and existing QA Technicians and Specialists as needed.
• Perform other duties as assigned.

• Maintain change management documentation, including assignment of Design History File (DHF) numbers.
• Compile and organize quality system records for design change projects, ensuring alignment with SOPs.
• Manage documentation storage, organization, and archival related to design changes and labeling.
• Provide proofreading and verification of product labeling prior to review and approval.
• Coordinate and implement labeling changes with internal teams and external partners.
• Assist with execution of product changes in collaboration with project leads.
• Manage assigned design change projects, typically related to product labeling.
• Perform other related duties as assigned.

• Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related technical field; or an equivalent combination of education and experience.
• Minimum of three years of experience in a Quality Assurance role within manufacturing.

• 3+ years of prior Quality Assurance or similar experience in the medical device industry.

• Strong adherence to procedures with accurate documentation skills.
• 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 documented procedures.
• Ability to read and interpret safety rules, operating instructions, and procedural documents.
• Strong written and verbal communication skills, including report writing and presenting to groups.
• Ability to interpret written, oral, diagrammatic, or schedule-based instructions.
• Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions.
• High attention to detail.

We are looking for the candidate who is eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button.