QA Specialist II (Quality Assurance Specialist II)

Maine Employer • Westbrook, ME • 15h ago

This job was posted by https://joblink.maine.gov : For more information, please see: https://joblink.maine.gov/jobs/1330632

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

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