-
ID
#19053740 -
Job type
Permanent -
Salary
TBD -
Source
Volt Services Group -
Date
2021-09-02 -
Deadline
2021-11-01
QA Specialist II
Maine, Scarborough, 04074 Scarborough USAPermanent
Vacancy expired!
- Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices).
- 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
- Initiate and author Deviations and Quality Incidents (QI)
- 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
- Change Control Management:
- Change Management Documentation
- 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)
- 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
- 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
- Ability to understand manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Vacancy expired!
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