Quality Assurance Specialist

Quality Assurance Specialist

Job Description

The position of Quality Assurance Specialist II is within our Client's Business Unit. In this role you will, under minimal direction, perform a wide variety of activities to support the Quality Management System.

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

Notes:
8:00 AM - 4:30 PM

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.