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Quality Assurance Technician

2 months ago

Warren, United States MassGenics Full time
Job Summary

We are seeking a highly skilled Laboratory Specialist to join our team at MassGenics. As a Laboratory Specialist, you will play a critical role in ensuring the quality and integrity of our laboratory operations.

Key Responsibilities
  • Carry out laboratory responsibilities in accordance with company policies, procedures, and regulatory requirements.
  • 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.
  • Ability to interpret and write general business documents and technical documents.
  • Ability to follow direction well, work cooperatively as an individual contributor and as a team member.
  • Ability to gown and maintain a sterile work environment.
  • Ability to work independently for extended periods of time.
  • Perform Environmental Monitoring on a routine basis.
  • Collect viable and non-viable samples within controlled environments.
  • Collect viable and non-viable samples for compressed gases.
  • Collect personnel glove and gown samples.
  • Participate in aseptic process qualifications, such as aseptic gowning and media reads.
  • Perform microbial isolation techniques and perform Gram stain identifications.
  • Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
  • Send out samples to contract labs and track results/reports.
  • Communicate effectively with QC peers, cross-functional peers, and management.
  • Perform general laboratory cleaning/wipe-down.
  • Perform routine maintenance of lab equipment.
  • Under the guidance of management, support special project work.
  • Document laboratory test results on worksheets, forms, and logbooks utilizing Good Documentation Practices.
  • Enter data in CELabs LIMS System.
Requirements
  • Bachelor's degree preferred, preferably in science or related field.
  • Microbiology lab experience strongly preferred.
  • Minimum 4 years of Environmental Monitoring experience.
  • Understand USP, EP, JP, and FDA microbiology testing requirements.
  • Intermediate level experience with Microsoft Word and Excel.
  • Experience using LIMS required; CELabs LIMS Systems preferred.
What We Offer

MassGenics offers a competitive salary and benefits package, including medical and pharmacy coverage, dental/vision insurance, 401(k), health saving account (HSA), and flexible spending account (FSA).

We are an equal opportunity employer and prohibit any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where we operate.