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Quality Control Sampler

Billerica, Massachusetts

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  • Full Time
  • Level: Entry
  • Glassdoor Reviews and Company Rating

Overview

You’re the one who will help us meet and exceed the quality standards that medical professionals and patients expect from us. Collaborating with like-minded, inventive colleagues, you’ll take a balanced approach, tackling challenges, learning from mistakes, and creating solutions that empower our fast-growing company. Join a workplace that’s big on open communication and fueling your career growth. When can you start?

Success Profile

What makes a great Quality Control Sampler at Sun Pharma? Take a look and see how you match up.

  • Collaborative
  • Communicator
  • Detail-oriented
  • Independent
  • Problem-solver
  • Team player

Our Culture

Discover an environment that’s open and transparent. Every day is a new opportunity to learn and grow, surrounded by powerful reminders of the impact your role has on patients’ lives. This is the Sun Pharma way of life. And we can’t wait for you to be a part of it.

Benefits

We’re in your corner – in so many different ways. Sun Pharma wants you to have the benefits, support, and rewards of a job well done.

  • Career Growth

    Get support for your career growth and development.

  • Benefits Programs

    Discover comprehensive benefits to support the health and wellness of you and your family.

  • Time Off

    Enjoy paid time off and leave-of-absence options.

  • Compensation

    Earn competitive compensation with incentive programs that reward our shared success.

  • Working Conditions

    Work confidently in the safe, clean, and regulated work environment that we foster.

  • Team Environment

    Collaborate in a workplace that’s rooted in our values and encourages cross-team engagement.

Quality Control Sampler

Billerica, Massachusetts
Category Quality Job ID R-43022
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Job Summary

The QC Sampler is responsible for sampling all incoming materials such as raw materials, packaging components, printed material and all other GMP materials using established Standard Operating Procedures (SOPs) and working in accordance with current Good Manufacturing Practices (cGMP).  Collect, sample, and prepare QC Chemical test samples for various analysis laboratories when required.

Area Of Responsibility

  • Sample all incoming materials and packaging materials per procedures.
  • Inspect all incoming GMP materials per materials specifications Inspect all incoming GMP materials per materials specifications including Identify non-conforming materials cleanliness and defects.
  • Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
  • Train towards Visual Inspection qualifications
  • Accurately sample and weigh Chemical test samples according to Material Specifications and SOP’s using, at times, sterile operating procedures
  • Perform QC Release testing for Visual Inspection of cosmetic defects and dimensional inspection of product container closure components
  • Initiate product non-conforming reports (UPD) as required (Track Wise) and investigate any problems noted with sampling/inspection process.
  • Issue/Dispense and receive labels and packaging materials per production batch record. Keep inventory of all product label/packaging materials
  • Enter transactions/transfers into SAP inventory control system
  • Maintain records/manual log books per good documentation practices (GDPs)
  • Coordinate scrap removal of rejected product
  • Update Raw Material Specifications (RMS)/(SOPs) as needed
  • Work under general supervision and follows established procedures and instructions
  • Operate and maintain the QC Chemical Sampling laboratory to GMP compliance and safety compliance
  • Operate, maintain and clean, and calibrate balances
  • Maintain laboratory supplies, reagents, chemicals, and equipment inventories for Sampling and Inspection laboratories
  • Manage calibration of instruments and equipment used for inspection and perform monthly equipment/ instrument maintenance and cleaning.
  • Other duties as assigned

Work Conditions:

Warehouse Environment

Laboratory environment:

  • Exposure to noise, bio-hazardous (live cultures), and chemicals
  • Exposure to non-hazardous and hazardous chemicals and materials
  • Moderate noise, oven heat, open flame, chemical fume hoods areas requiring wearing appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)

Physical Requirements:

  • Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.
  • Able to operate basic mechanical tools (i.e.:) calipers, micrometers, and go no-go gages
  • Able to drive a fork truck/tow motor/operate forklift
  • Close vision; depth perception; ability to adjust focus
  • Use of repetitive motion
  • Able to operate computer/office machines
  • Able to lift and carry up to 50 lbs.

Travel Estimate

Up  to  5 %

Education and Job Qualification

  • Minimum of High School/Trade School/Vocational School Diploma, GED, or equivalent.  B.S. degree preferred.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
  • Good oral and written communication skills and ability to use these skills to follow specific instruction and report assay results (i.e. written SOPs)
  • Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
  • Fundamental knowledge of chemical principles
  • Proficient with basic laboratory instrumentation.
  • Use of Track Wise software and knowledge of SAP is preferred.
  • Use of Lotus Notes software
  • Working knowledge of Microsoft Office Applications.
  • A self-starter with a hands-on approach and a can-do attitude.

Experience

  • Minimum of two (2) years of experience required in a Pharmaceutical/drug (FDA Regulated) industry preferred

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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