Quality Assurance Specialist

Quality Assurance Specialist II8-month ContractOnsite in Scarborough, MEMust be able to work on a W2 RequirementsReview production batch records (DHRs) for accuracy and completeness to approve intermediate and finished goods; report and ensure resolution of deviations prior to approvalConduct spot-check inspections and audits of production operationsParticipate in the internal audit programWrite, review, and approve Standard Operating Procedures (SOPs) as neededAssist with and author validations and test protocols as necessaryTest complaint and stability samples; report results outside of acceptance limitsInitiate and author Deviations and Quality Incidents (QI)Provide backup support to other Quality SpecialistsAdminister or support calibration, document control, deviation, Quality Incident, CAPA, quality records, and sample retention programs as assignedOrganize and administer long-term stability programs as assignedTrain Quality Assurance Technicians and Specialists as neededManage change control documentation, including assignment of Design History File numbersCompile, maintain, organize, store, and archive quality system records related to design change projectsEnsure design change records are complete and aligned with SOPsProofread product labeling prior to review and approvalInitiate, execute, and implement labeling changes in coordination with internal and external stakeholdersAssist with implementation of product changes and manage assigned design change projectsPerform other duties as assignedQualificationsBachelor’s Degree in Chemistry, Biology, Life Science, or related technical field, or equivalent combination of education and experienceMinimum three years of experience in a Quality Assurance role within manufacturing3+ years of experience in a Quality Assurance or similar role in the medical device industry (preferred)Ability to follow procedures and accurately document resultsKnowledge of inventory management, document control, and quality incident tracking systemsProficiency in Microsoft Excel and WordUnderstanding of manufacturing processes and ability to identify deviations from approved proceduresAbility to read and interpret safety rules, operating instructions, and procedure manualsAbility to write routine reports and correspondenceAbility to communicate effectively with groups of employees or customersAbility to interpret written, oral, diagram, or schedule-based instructionsAbility to apply mathematical concepts such as fractions, percentages, ratios, and proportionsStrong attention to detail