QA Specialist/Quality Assurance

Role: QA Specialist II Location: Scarborough, ME - 04074 Duration: 08 Months

• Summary:• The position of Quality Assurance Specialist II is within our Infectious Disease Business• Unit 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 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• Other duties may be assigned.• 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)

• 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 experience• Minimum 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 industry

• COMPETENCIES:• Ability to follow procedures and accurately document results• Knowledge of site software for inventory management, document control and quality• incident tracking• Good working knowledge of Excel and Microsoft Word software• Ability to understand manufacturing processes of Company products and ability to• recognize deviations from approved documented procedures• Ability to read and interpret documents such as safety rules, operating and maintenance• instructions, and procedure manuals• Ability to write routine reports and correspondence• Ability to speak effectively before groups of customers or employees of organization• Ability to interpret a variety of instructions furnished in written, oral, diagram, or• schedule form• Ability to apply mathematical concepts such as fractions, percentages, ratios, and• proportions to practical situations• Attention to detail