QA Specialist II

Title: QA Specialist II
Location: 10 Southgate Road, Scarborough, Maine 04074
Duration: 12 Months | 100% Onsite
Pay Range: $30?$33 per hour (W2)

We are seeking a QA Specialist II to join one of our leading healthcare clients.

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.

Responsibilities
Quality System Management

• Review production batch records (DHRs) for accuracy and completeness to approve intermediate products for production use; review finished goods batch records. Report any 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 Standard Operating Procedures (SOPs) as required.
• Assist with the 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 Quality Assurance 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 (e.g., project definitions, first-lot-to-stock, qualification records), 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 are eligible to work with any employers without sponsorship.

If you?re interested, please click ?Apply? button.