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27 days old

Senior Quality Control Microbiology Analyst (direct hire)

Kelly Services
Allendale, NJ 07401
**Senior Quality Control Microbiology Analyst (direct hire)**


**Overview:** Kelly Services is seeking a motivated, enthusiastic individual to join our clients team as a Quality Control Microbiology Analyst. This is a direct hire position based in Allendale, NJ for a leader in cell and gene therapy. This role is a 1 st shift position with a 4/10 schedule, i.e. 4 work days @ 10 hours per day, either Sunday Wednesday, or Wednesday through Saturday.


This position will report into the Supervisor of QC Microbiology. The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring.


**Essential Functions and Responsibilities**


Under the direction of the Supervisor of QC Microbiology, responsibilities of the QC Microbiology Analyst III will include but are not limited to:


- Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).


- Coordinates data for batch release


- Participation in project/client meetings and communications, providing scientific and technical expertise


- Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols


- Review of investigations and documentation of non-confirming events and environmental excursions.


- Apply expertise of compliance requirements to maintain an inspection-ready state.


- Participate and act as subject matter expert during audits/inspections


- Develop and train QC Microbiology Analyst II on relevant business processes


- Processing of purchase orders for outsourced testing and lab supplies


- Coordinates work orders


**Qualifications**


- BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry


- Proficient with computer software such as Microsoft Office. MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred)


- Proficient knowledge of ISO and EU standards


- Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.


- Strong written and oral communication skills


- Strong technical writing skills / technical training experience


- Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities


Please note that resumes from third parties will not be accepted. All candidates must be presently authorized to work for any employer in the US.


Apply today for immediate consideration or send your resume directly to


**MarH823@kellyservices.com**


**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-28 Expires: 2021-06-28

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Senior Quality Control Microbiology Analyst (direct hire)

Kelly Services
Allendale, NJ 07401

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