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Microbiology Testing Lead

Employer
Alpha Consulting
Location
Summit, New Jersey, US
Salary
Competitive
Closing date
Jul 22, 2021

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
MICROBIOLOGY TESTING LEAD
SUMMIT, NJ
Working onsite in laboratories handling human cells.

Project Description:
This position will work both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary.
  • Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
  • Follow directions properly, work cooperatively as an individual contributor and as a team member.
  • Communicate effectively with QC peers, cross-functional peers and management.
  • Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
  • Train Bacterial Endotoxin and Sterility Testing.
  • Train growth promotion testing of microbiological media.
  • Train mycoplasma testing via PCR.
  • Train Environmental Monitoring on routine basis.
  • Train microbial isolation techniques and perform Gram stain identifications.
  • Train "Send out samples to contract labs and track results/reports.
  • Performs general laboratory cleaning/wipe-down.
  • Perform routine maintenance of lab equipment's.
  • Under the guidance of management, support special project work.
  • Maintain lab inventory and order lab supplies and materials.
  • Support continuous improvement projects related to QC.
  • Assist with investigations & CAPAs associated with Microbiological testing.
  • Support data trending and tracking of results.
  • Perform all other duties as assigned.

Required Skills:
  • Requires Bachelor's degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment.
  • Microbiology lab experience & Master's Degree strongly preferred. An equivalent combination of experience/education is acceptable.
  • Experiences on HPLC, UPLC, or GC is plus.
  • Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
  • Good knowledge of Microsoft Word and Excel.
  • Responds to challenges and additional projects in an understanding, positive, and objective manner.
  • Adaptable to dynamic conditions, work practices, and project timelines.
  • Ability to multitask, prioritize workload and interpret data accurately.
  • Able to communicate effectively with GDPO functional areas and external agencies.
  • Fosters teamwork and promotes an environment that motivates others to achieve our goals.
  • Position Handles Hazardous Materials
Working Conditions:
  • The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment.
  • The incumbent may be required to stand and walk for extended amount of time.
  • The incumbent may be required to work hazardous materials.
  • Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
  • Flexible to work shift structures.
  • Change to work timings and assigned tasks may occur at a very short notice to support business needs.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Vic: vic@alphaconsulting.com

ALPHA'S REQUIREMENT #21-02104
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#ZR#LI-VB1

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