RCI-ABO-44820 Quality Assurance Specialist (DHR/CAPA/Deviations/Risk Management/Change Control/Audit) (Medical Device)

Manager is seeking one Quality Assurance Specialist, II to support a need in the Scarborough, Maine location. Candidates local to Maine are preferred, followed by those in the New England area. Mgr advises that this position needs someone with background/ experience in risk review and risk management. Description:The position of Quality Assurance Specialist II is within our Infectious Disease BusinessUnit located at Scarborough, Maine. In this role you will, under minimal direction, perform a wide variety of activities to support the Quality Management System.This job description will be reviewed periodically and is subject to change by management.RESPONSIBILITIES:The following activities may be assigned as applicable:Quality System ManagementReview production batch records (DHRs) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report deviations in these records and assure they have been addressed and resolved prior to issuing approval.Conduct spot-check inspections/audits of production operationsParticipate in the internal audit programWrite, review and approve Standard Operating Procedures (SOPs) as necessaryAssist with and may write validations/test protocols as necessaryAssist in testing of complaint samples and stability samples and report results out of acceptance limitsProvide backup to other Quality SpecialistsInitiate and author Deviations and Quality Incidents (QI)May administer the calibration programMay administer the document control systemMay administer the Deviation, Quality Incident and CAPA programsMay organize the long-term stability program and be responsible for administering the sample retention programMay administer the Quality Records program and assist and act as backup to the Document Control Specialist IITrain new and current Quality Assurance Technicians and Specialists as neededOther duties may be assigned.Change Control ManagementChange Management DocumentationAssignment of Design History File numbersCompile 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 SOPsManage organization, storage, and archival of documentation and records associated with design changes and labelingLabeling Process Administration:Provide proofreading of product labeling prior to team review and approval Initiate, execute and implement label changes in coordination with interdepartmental and external stakeholdersChange Control Execution:Assist with implementation of product changes, in conjunction with project leadsManage assigned Design Change projects (typically associated with product labeling)Other duties may be assigned.BASIC QUALIFICATIONS | EDUCATION:Bachelor's Degree in Chemistry, Biology, Life Science, or other related technical field in a scientific or technical area or the equivalent combination of education and experienceMinimum three years in a Quality Assurance role for manufacturing.PREFERRED QUALIFICATIONS:3+ years prior experience in a Quality Assurance role or similar support role in the medical device industryCOMPETENCIES:Ability to follow procedures and accurately document resultsKnowledge of site software for inventory management, document control and quality incident trackingGood working knowledge of Excel and Microsoft Word softwareAbility to understand manufacturing processes of Company products and ability to recognize deviations from approved documented proceduresAbility to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manualsAbility to write routine reports and correspondenceAbility to speak effectively before groups of customers or employees of organizationAbility to interpret a variety of instructions furnished in written, oral, diagram, or schedule formAbility to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situationsAttention to detail