Quality Control Analyst I

Celldex TherapeuticsFall River, MA
$66,413 - $86,250Onsite

About The Position

Individual is responsible for performing and understanding all tasks associated with Environmental Monitoring, Purified Water and raw material sampling and testing to support the Fall River Manufacturing facility.

Requirements

  • Associate’s or Bachelor’s degree in Biology, Chemistry, or related discipline.
  • 0-2 years of experience in the biotech / pharmaceuticals industry.
  • Adaptable to last-minute changes.
  • Strong communication and organizational skills.
  • The ability to work independently and as part of a team.
  • Flexibility in schedule for performing testing during weekdays, weekends, and holidays.

Nice To Haves

  • Experience with cGMP and aseptic technique preferred.

Responsibilities

  • Environmental monitoring of air, equipment and surfaces in ISO Class 5, ISO Class 7 and ISO Class 8 clean rooms, including in-process and personnel monitoring.
  • Sampling USP/EP Purified Water system aseptically.
  • Perform the enumeration and identification of microorganisms isolated in the facility.
  • Perform microbial bioburden and TOC on USP/EP Purified Water/equipment cleaning samples.
  • Growth promotion of media used in Environmental monitoring and product testing.
  • Perform cleanroom gowning qualifications.
  • Raw material sampling and ID testing.
  • Database entry for trending programs and data filing.
  • Participate in SOPs revisions and annual summary reports.
  • Perform inventory and order chemicals and general lab supplies.
  • Maintain equipment and glassware.
  • Perform other additional job-related duties as required.

Benefits

  • annual discretionary bonus
  • long term incentive
  • 401(K) plan with employer contribution
  • health care and other insurance benefits (for employee and family)
  • paid holidays
  • vacation
  • sick days
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