Manufacturing Associate II (Fulltime, Days)

Location: Milford, MA
Job Code: 505
# of openings: 1

Description

Manufacturing Associate II   (Fulltime, Days)

SeraCare develops and manufactures controls and reference materials and related products for In vitro diagnostics. We focus on infectious disease, oncology, inherited diseases and maternal fetal medicine. SeraCare is the best in the world at developing and manufacturing disease mimetics which are biosynthetic or engineered versions of human disease material. We partner with IVD researchers, manufacturers and clinical laboratories to bridge the gap between today’s diagnostic solutions and tomorrow’s emerging technologies for molecular diagnostics, next generation sequencing and companion diagnostics. With more than 25 years of diagnostic industry experience, SeraCare is uniquely positioned to ensure the highest level of consistency, confidence and compliance as we jointly shape the future of medical diagnostics

SUMMARY: 

The Manufacturing Associate II provides direct labor for the manufacturing of high quality diagnostic products using manual and semi-automated equipment and prepares/completes required documentation on manufacturing procedures. This position is responsible for set-up, calibration, and operation of all manufacturing equipment in accordance with cGMP, POPs, SOPs, Safety, and departmental policies.  This position utilizes good judgment and critical thinking skills to make operator level decisions regarding the quality of the products manufactured.

POSITION DETAILS:

  • Minimum 0.5 years in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role.
  • High School Diploma; Preferred Bachelor’s degree, with a concentration in Biology, Chemistry or related science
  • Preferred experience with Microsoft Software (Word, Excel, Office).
  • Preferred SAP / Oracle ERP system experience.
  • Preferred experience with 5S and Lean implementation
  • Preferred label printing software experience.

RESPONSIBILITIES:

  • Prepare products according to approved Manufacturing Process Operating Procedures (POP’s), Standard Operating Procedures (SOP’s), cGMP and ISO 13485 quality systems.  Responsible for performing all manufacturing processes assigned while following all departmental policies (safety) assigned with minimal error.
  • Review all documentation for inaccuracies before starting and notify supervisor and/or manager of any discrepancies without delay.  Obtain prior authorization for any deviation.
  • Take required action to accomplish scheduled workload. 
  • Maintain work area in a clean and orderly fashion.
  • Promote positive teamwork and continuous improvement ideas

CANDIDATE ATTRIBUTES:

  • Possess a strong work ethic, be performance driven, ability to multi-task /prioritize and have excellent organizational skills.
  • Initiative to understand and complete the existing workload and with minimum direct supervision.
  • Communicate & Collaborate with other functions in the performance of day to day activities.
  • Adaptable, with the capacity/flexibility to respond to the demands of a growing/changing company. 

 

Benefits: The position is full-time, with competitive pay, excellent benefits including medical, dental & vision, generous Paid Time Off (PTO), Life Insurance, STD/LTD and a 401(k) plan with a match. SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V





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