Microbiology Testing Lead

Employer
Alpha Consulting
Location
Summit, New Jersey, US
Salary
Competitive
Posted
Jun 24, 2021
Closes
Jul 22, 2021
Ref
2273296338
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
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

Similar jobs

Similar jobs