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RESPONSIBILITIES:
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
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
records, etc.
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
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.
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
Job Type: Full-time
Pay: $20.00 - $25.00 per hour
Benefits:
Schedule:
Work Location: In person
Full Time
$75k-91k (estimate)
08/25/2024
09/08/2024
The job skills required for Quality Assurance Technician include Quality Assurance, Internal Audit, Attention to Detail, Calibration, Change Control, Chemistry, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Technician. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Technician. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Assurance Technician positions, which can be used as a reference in future career path planning. As a Quality Assurance Technician, it can be promoted into senior positions as a Quality Assurance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Technician. You can explore the career advancement for a Quality Assurance Technician below and select your interested title to get hiring information.