Skip to main content
Search Jobs
we need more: Supportive Team mates ready to face any challenge.

Associate, QC Compliance

Billerica, Massachusetts

Apply
  • 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 Associate, QC Compliance 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.

Associate, QC Compliance

Billerica, Massachusetts
Category Quality Job ID R-32591
Apply

Job Summary

The Associate Quality Control - Compliance role is a dual function role.  The role is divided between QC compliance activities and QC laboratory GMP testing activities.  Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance with current Good Manufacturing Practices (cGMPs).  Monitors and evaluates systems, equipment, records and trends data.  Review/revise documentation (i.e. SOPs).  Works under limited supervision following established procedures. Timely closure of QMS records, site actions, implementation of Sun global quality standards, and validity of departmental SOPs.

Area Of Responsibility

  • Perform release, stability, validation and complaint (follow-up) analytical quality control tests and assays on raw materials, in-processing and final products Following GLPs
  • Perform quality control tests and assays including USP test methods and EP test methods
  • Monitor, calibrate, maintain and evaluate systems or equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
  • Analyze data and interpret results.  Maintain data records in manual or computer based logs following GDPs
  • Maintain data records in manual or computer based logs following GDPs
  • Support to QC maintained all the time for internal and external audits following guideline including USFDA, Health Canada,  cGMP, ISO, GLPs, company policies and procedures.   
  • Support to assure timely closure of quality management system (QMS) records, site actions, implementation of global quality standards, and validity of departmental SOPs.  Use of Trackwise to create, populate, investigate, and close event records (OOS, CAPA, UPD, PD, CC, etc.).  Investigation leadership will be a plus.
  • Send samples to contract laboratories and collect test data
  • Wash glassware, prepare reagents, solutions, equipment for chemical tests and assays
  • Able to operate complex laboratory instrumentation to analyze product
  • Perform monthly equipment/instrument maintenance and cleaning
  • Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
  • Train towards Visual Inspection qualifications
  • Other duties as assigned

Work Conditions:

  • Office
  • Labs with moderate noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
  • Work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases and radioactive materials
  • Exposure to or use of syringes and needles
  • Requires access/work in chemical fume hoods
  • Requires access/work in class 100K, 10K or 100 clean room (mask and boots in conformance with environmental dress codes)

Physical Requirements:

  • Stand, walk, sit, use hands and  fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
  • Close vision
  • Lift up to 25 lbs.
  • Operate computer/office machines
  • Ability to wear Personal Protection Equipment

Travel Estimate

Up to 5%

Education and Job Qualification

  • B.S. in a related scientific major required
  • Good oral and written communication skills
  • Ability 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
  • Understanding of cGMPs and GLPs
  • Strong analytical skills with attention to detail
  • Able to perform basic troubleshooting and repair of complex instrumentation
  • Proficient computer skills including word processing and spread sheet programs

Experience

  • Minimum 2-4 years related experience
  • Use of Trackwise, Novatech, and Empower software

The presently-anticipated base compensation pay range for this position is $85,000 to $104,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees 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 the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice To Agency And Search Firm Representatives

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Apply
Explore this area

Jobs for You

You have no recently viewed jobs.

You have no saved jobs.

Get Job Alerts

Sign up below to receive job alerts, our monthly newsletter, and advice from our recruiters straight to your inbox.

Woman using a laptop

Job Alerts

Areas of InterestSearch for a category, location, or category/location pair, select a term from the suggestions, and click "Add".

  • Quality, Billerica, Massachusetts, United StatesRemove