Quality Assurance Specialist II
10 Southgate Rd Scarborough, ME 04074 US
*Depending on experience
The position of Quality Assurance Specialist II is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will under minimal direction, the scope of this position is to 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.
Quality System Management
? Review production batch records (DHR's) 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 assures these 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 reports 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 program
? 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 (with administrator rights in site electronic
? Train new and current Quality Assurance Technician and Specialists as needed
? Other duties as assigned
Change Control Management
? Change Management Documentation
o Assignment of Design History File numbers
o Compile and maintain quality system records associated with design change
projects, including project definitions, first-lot-to-stock, product qualification
o Ensure records for design change projects are complete and align with SOPs.
o Manage organization, storage, and archival of documentation and records
associated with design changes and labeling.
? Labeling Process Administration:
o Provide proofreading of product labeling prior to team review and approval.
o Initiate, execute and implement label changes in coordination with
interdepartmental and external stakeholders.
? Change Control Execution:
o Assist with implementation of product changes, in conjunction with project leads.
o Manage assigned Design Change projects (Typically associated with product
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.
? 3+ years prior experience in a Quality Assurance role or similar support role in the medical
? Ability to follow procedures and accurately document results
? Knowledge of site software for inventory management, Document Control and Quality
? 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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.