in Cumberland County, ME
Job Description
Job Description:
- 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
