Quality Assurance Specialist II
Scarborough, Maine, United States
Job type: fulltime
Job industry: Other
Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
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 documentation system).
Train new and current Quality Assurance Technician and Specialists as needed
Other duties as assigned
Change Control Management
•Change Management Documentation
oAssignment of Design History File numbers
oCompile and maintain quality system records associated with design change projects, including project definitions, first-lot-to-stock, product qualification records, etc.
oEnsure records for design change projects are complete and align with SOPs.
oManage organization, storage, and archival of documentation and records associated with design changes and labeling.
•Labeling Process Administration:
oProvide proofreading of product labeling prior to team review and approval.
oInitiate, execute and implement label changes in coordination with interdepartmental and external stakeholders.
•Change Control Execution:
oAssist with implementation of product changes, in conjunction with project leads.
oManage assigned Design Change projects (Typically associated with product labeling)
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 device industry.
•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
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.