QA III, Microbiology
Company: Randstad
Location: Billerica
Posted on: March 16, 2023
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Job Description:
Onsite in Billerica, MA Summary Perform testing on incoming
materials, finished products and stability studies in QC
Laboratory. Key Responsibilities/Essential Functions Perform
routine QC testing in accordance with SOPs and cGMP guidelines.
Some supervision required. Perform verification of data to ensure
accuracy. Perform approval upon discretion of supervisor. Assist
with audit readiness of laboratory area and calibration and
maintenance of laboratory equipment. Utilize a range of electronic
systems such as LIMS and document/equipment management software.
Author SOP changes; participate in change controls, CAPAs, other
quality systems. Resolve routine problems by utilizing appropriate
resources. Assist in investigations. May assist on special projects
as needed. Help with continuous improvement. Train on and maintain
knowledge of current regulatory requirements and relevant internal
procedures. Team player who can work independently with quality and
attention to detail. Good communication skills both oral and
written, professional conduct. Effectively and efficiently
participate in assigned tasks in a quality manner. Actively promote
safety rules and awareness. Reports and takes initiative to correct
safety & environmental hazards. Work with potentially hazardous
chemical, radiological and/or biological materials on a daily
basis. Demonstrate good safety practices at all times including the
appropriate use of protective equipment. Actively demonstrates the
values of accountability, communication, customer commitment,
entrepreneurial spirit, integrity, safety and teamwork. *In case of
absence the Reports to Manager above or a peer incumbent will
function as a backup for this position. Area Specific Requirements
Familiar with aseptic technique Perform routine Environmental
Monitoring and utilities testing Perform sterility, microbial
limits and Endotoxin testing, identify and trend microorganisms
Basic Qualifications Typically requires 1-3 years of previous
experience in the pharmaceutical industry, related GMP environment,
or equivalent. Previous experience preferred. Requires a BA/BS
degree in a related scientific discipline (e.g. chemistry, biology)
or equivalent combination of education and experience. Other
Requirements Some non-routine travel may be required. Flexibility
with scheduling requirements-may include shifts, overtime, weekends
and holiday coverage, including during adverse weather conditions.
Must be able to lift 50 lbs.
Keywords: Randstad, Billerica , QA III, Microbiology, Other , Billerica, Massachusetts
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