Title QA Specialist II Location Scarborough, Maine Duration 9 Months Employment Type 100% Onsite Qualifications 3+ years prior experience in a Quality Assurance role or similar support role in the medical device industry. Minimum three years in a Quality Assurance role for manufacturing. 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 experience. Responsibilities Quality System Management Review 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 operations. Participate in the internal audit program. Write, review and approve Standard Operating Procedures (SOPs) as necessary. Assist with and may write validations/test protocols as necessary. Assist in testing of complaint samples and stability samples and report results out of acceptance limits. Provide backup to other Quality Specialists. Initiate and author Deviations and Quality Incidents (QI). May administer the calibration program. May administer the document control system. May administer the Deviation, Quality Incident and CAPA programs. May organize the long-term stability program and be responsible for administering the sample retention program. May administer the Quality Records program and assist and act as backup to the Document Control Specialist II. Train new and current Quality Assurance Technicians and Specialists as needed. Change Control Management Change Management Documentation. Assignment of Design History File numbers. Compile 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 SOPs. Manage organization, storage, and archival of documentation and records associated with design changes and labeling. Labeling 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 stakeholders. Change Control Execution Assist with implementation of product changes, in conjunction with project leads. Manage assigned Design Change projects (typically associated with product labeling). Consultants Eligible Benefits Upon Waiting Period Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. #J-18808-Ljbffr