Quality Assurance Specialist
Location
Louisville, CO | United States
Job description
Quality Assurance Specialist – Louisville, CO
Type: Contract (6 months, potential for extension)
Shift: M-F 8a-5p
Pay Rate: $37-$45/hr
Job Responsibilities - Works effectively cross-functionally across Umoja to fulfill Vendor Management responsibilities.
- Coordinates the supplier notification and change process, working with cross-functional SMEs to assess and document impact.
- Coordinates the Supplier Corrective Action Record (SCAR) process and material defect management process.
- Supports vendor recertification events for identified vendors in collaboration with cross-functional SME.
- Provide administrative support for the Vendor Management program, as needed.
- Executes controlled document archival process, when required.
- May review and approve Standard Operating Procedures (SOPs) and other controlled documents
- Provides additional support within the Quality organization, as needed
- Potential to support organizations outside of Quality, if needed, to accomplish facility startup objectives and routine operations.
Requirements: - Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 2 years of work experience in an FDA regulated industry.
- An understanding of quality management systems and vendor management.
- Knowledge of relevant pharmaceutical regulations and regulatory guidance.
- Strong communication and organizational skills and a passion for teamwork.
- Ability to work effectively and efficiently in a collaborative manner across multiple functional areas.
Preferred Qualifications: - Previous experience with a vendor management program in a cGMP environment.
- Previous experience in a Quality organization supporting a current Good Manufacturing Practice (cGMP) biopharmaceutical manufacturing facility startup and/or operations environment.
- Experience in cGMP cell and gene therapy manufacturing and/or testing facility.
Physical Requirements: - Ability to gown aseptically and work in a Clean Room environment, if required
- Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required
- Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
- Ability to primarily work onsite, working remotely when appropriate.
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