Back to results: internal audit abroad / US

Quality Assurance Specialist

Kelly Services

Posted on: 28 Mar 2024

Job Location: Louisville, US

Job Description:

Job details

Quality Assurance Specialist - Louisville, CO

Type: Contract (6 months, potential for extension)

Shift: M-F 8a-5p

Pay Rate: $47-$57/hr

REQUIREMENTS

Provide on the floor Quality oversight to Manufacturing operations and other functional areas, where needed.
Reviews executed batch records.
Review and approve deviations, CAPAs, and Change Controls.
Reviews and approves work orders in the computerized maintenance management system (CMMS)
Reviews and approves material specifications and performs material disposition.
Reviews and approves Master Batch Records, process SOPs, and supporting forms.
Reviews and approves of Standard Operating Procedures.
Partners with other departments (e.g., Manufacturing, MSAT, Supply Chain, Facilities and Engineering, and Quality Control) to ensure compliance with all applicable procedures, policies, and standards.
Provides additional support within the Quality organization, as needed.

The successful candidate will have:

Bachelor's degree in Engineering, Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with minimum of 5 years of work experience in an FDA regulated industry.
Knowledge and understanding of regulatory governing bodies, requirements, and guidance documents, and how to practically apply these in a cGMP biopharmaceutical environment.
An understanding of foundational Quality systems (e.g., audits/inspections, Change Control, Deviation/CAPA, etc.).
Independent and risk-based decision-making capability with clear understanding of decision-making impact in dynamic cGMP environment.

Preferred Qualifications:

Previous Quality experience in cGMP biopharmaceutical manufacturing facility startup 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 work while gowned for extended periods of time, if required
Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required
Use of laboratory and manufacturing equipment includes handling chemicals and biological materials.
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 work occasional nights and weekends as needed.
Ability to primarily work onsite, working remotely when appropriate.

For Immediate Consideration, Apply Today!

#P2

9298215

Apply

Similar jobs

Quality Assurance Specialist

Louisville, US

28 Mar 2024

Quality Assurance Specialist

Louisville, US

28 Mar 2024

Quality Assurance Specialist

Louisville, US

28 Mar 2024

Quality Assurance Specialist

Louisville, US

28 Mar 2024