Quality Control Specialist

3 days ago

Edison, New Jersey, United States MTF Full time
Job Title: Quality Control Technician

MTF Biologics is seeking a highly skilled Quality Control Technician to join our team. As a Quality Control Technician, you will be responsible for performing and documenting daily, weekly, and monthly environmental monitoring activities within a strict ISO Class clean room environment.

Responsibilities:
  • Operate critical, highly specialized air sampling equipment within a strict aseptic clean room environment and ensure equipment is working as intended and is appropriately calibrated.
  • Perform critical, time-sensitive environmental sampling of the MTF clean room aseptic processing facility, including non-viable air sampling, viable air and surface sampling, water and LAL sampling, and nitrogen system testing.
  • Assist in providing weekly or monthly trending and reporting of environmental testing data.
  • Schedule and document calibration and maintenance for clean room and laboratory equipment.
  • Input calibration data into the BRAM database and identify when NCRs need to be generated.
  • Monitor calibration files and provide monthly due and past due lists to equipment owners.
  • Generate any necessary nonconformance reports, perform the necessary investigations, direct any necessary actions, complete the required documentation, and follow up to ensure the nonconformance is resolved in a timely manner.
Qualifications:
  • 1 year of experience in GMP or FDA regulated industry.
  • Must be able to maintain qualification as per the gowning and gloving procedure for entrance into the clean room environment.
  • Excellent manual dexterity skills to operate equipment and to obtain other environmental samples.
  • Must exhibit attention to detail, critical thinking, problem-solving and effective communication skills.
  • Must be proficient in data entry, Microsoft Outlook, Word, and Excel.

MTF Biologics is an equal employment opportunity employer and welcomes applications from diverse candidates. If you are interested in this opportunity, please submit your application through our website.

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