Quality Assurance Engineer
Company: Kelly Services
Location: Commerce City
Posted on: April 9, 2021
Quality Assurance EngineerTemp to Hire$38.00 per hourIn this
fast-paced environment, Quality Assurance Associates/Engineers work
collectively to provide continuous oversight of all GMP operations
encompassing materials, manufacturing, testing, and facility
operations. This position will also be responsible for assisting
with the administration and continuous improvement of the QMS.
These responsibilities require a high degree of accuracy and
attention to detail. The ability to work well independently as well
as in a team environment is crucial as the position reports to
Quality Assurance Supervisor and communicates regularly with all
levels of personnel within the Company's--external vendors and
- Provide GMP support for the contract manufacture of protein
biologics and cell/gene therapies to enable and support early-phase
(i.e. Phase 1) clinical trials.
- Drive continuous improvement to key quality operational
procedures and systems including authoring new SOPs as well as SOP
revisions and proving training on these procedures and
- Review/approve key manufacturing, testing, equipment,
utilities, facilities documentation including batch records,
deviations/investigations, test data, and qualification protocols
- Provide Quality input and approval on deviations,
investigations, environmental monitoring excursions, Out of
Specification (OOS) results, Corrective and Preventive Actions
(CAPA) and change controls.
- Provide Quality authorization of line clearance of GMP
- Assist in establishing specifications for equipment, processes,
raw materials and final product in conjunction with Subject Matter
Experts and clients.
- Issue documents and labels to Operations for product runs and
reconciliation of documents and labels after a production run;
ensure approval of batch specific final product labels
- Assist in all aspects of document control.
- Assist in performing audits of the facility and follow up on
reconciliation of any findings via formal reports and
- Resolve vendor issues including aspects of supplier corrective
- Support materials management including release/quarantine of
materials and investigation into non-conforming materials.
- Assist in the administration of the GBF site-wide training
- The position will require occasional evening/weekend work to
accommodate operational activities that may occur outside of normal
business hours. While not typical, this irregularity of work hours
should be expected. Minimal travel is expected.Minimum
- A master's degree in Engineering, Biological Sciences, or a
- 3+ years of experience in a Quality Assurance operational role,
mainly in the production oversight of pharmaceuticals, biologics
and/or cell/gene therapies.
- Demonstrated experience in batch record review and analytical
review of GxP batches
- Solid knowledge of Good Manufacturing Practices (GMPs) in
regard to clinical manufacturing operations and compliance with 21
CFR 11, 28, 210, 211, 600, 1271, and FACT regulations.
- Demonstrated ability to operate an electronic quality
management system.Preferred Qualifications:
- Experience with aseptic techniques, gowning practices and
general operations within an ISO-controlled, clean room
- Comprehensive understanding of risk management and root cause
analysis tools (e.g. FMEA, Ishikawa, Fishbone, etc.).
- Operational experience leading materials non-conformances,
deviations, investigations, out of specification results, and
- Experience working in a Just in Time (JIT) environment relating
to manufacturing, material procurement, kitting, release and
distribution of finished product.Knowledge, Skills and Abilities:
- Ability to work in a fast paced, highly collaborative
environment with a demonstrated commitment to develop long-term
relationships with colleagues, clients, and community is
- Must be a goal-oriented, self-starter capable of operating both
independently and as a part of a team in a start-up
- Detail oriented with good organizational, communication and
time management skills.
- Able to identify, communicate, report and correct quality
concerns effectively and efficiently.
- Good oral and written communication skills across all levels of
internal personnel, company staff, vendors or clients.
- Experience in the Microsoft Office suite including MS Word,
Excel and Outlook.
- Administration and routine use of electronic document
management systems (e.g. Documentum, etc.), strongly
- Operational use of electronic resource planning (MRP/ERP)
and/or inventory management systems, highly desirable.Why
Kelly--?Kelly Science & Clinical is your connection to premier
scientific and clinical companies looking to hire talented people
just like you. Every day, we match science professionals with dream
jobs that fit their skills and interests-it's the way we think job
searching should be. Nearly 100 percent of our science recruiters
have a professional background/education in science, so we know a
thing or two about the science market and how to get you
noticed.About Kelly--At Kelly, we're always thinking about what's
next and advising job seekers on new ways of working to reach their
full potential. In fact, we're a leading advocate for
temporary/nontraditional workstyles, because we believe they allow
flexibility and tremendous growth opportunities that enable a
better way to work and live. Connecting great people with great
companies is what we do best, and our employment opportunities span
a wide variety of workstyles, skill levels, and industries around
the world. Kelly is an equal opportunity employer committed to
employing a diverse workforce, including, but not limited to,
minorities, females, individuals with disabilities, protected
veterans, sexual orientation, gender identity. Equal Employment
Opportunity is The Law.]]
Keywords: Kelly Services, Commerce City , Quality Assurance Engineer, Other , Commerce City, Colorado
Didn't find what you're looking for? Search again!