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QA Specialist II

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 QA Specialist II 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.

QA Specialist II

Billerica, Massachusetts
Category Quality Job ID R-46950
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Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. 

Job Summary:

The QA Specialist II is responsible for ensuring compliance with Current Good Manufacturing Practices (cGMP) in the production of pharmaceutical and medical device products. This role provides Quality Assurance support across manufacturing operations, including batch record review, raw material release, and oversight of GMP activities. The specialist will conduct documentation reviews, perform line clearances, support internal audits, and contribute to continuous improvement initiatives. The ideal candidate brings experience in a cGMP-regulated environment, strong attention to detail, and the ability to work independently while collaborating across departments to uphold quality standards.

Schedule:

2nd Shift - Monday - Friday, 12:00pm - 8:30pm

Areas of Responsibility:

  • Review manufacturing batch records and quality control testing data for lot release and stability, ensuring conformance to approved procedures and cGMP 

  • Review SOPs, logbooks, and other documentation related to daily QA activities including raw material release. 

  • Perform QA coverage of GMP operations including manufacturing, labeling/packaging, QC testing, warehouse  

  • Perform walkthroughs of GMP areas documenting observations and areas of concern. 

  • Complete monthly QA metrics 

  • Perform line clearances in manufacturing areas including labeling/packaging 

  • Support internal audits of cGMP operating groups as necessary to ensure compliance to cGMP,  internal procedures and policies 

  • Write and/or review Standard Operating Procedures  

  • Review and approve document change controls 

  • Review and approve CAPA, PRA and non-conforming product reports 

  • Execute continuous improvement projects as assigned 

  • Other duties as assigned 

Job Qualifications and Experience:

  • BS in life science preferred or equivalent related experience 

  • Works under limited supervision using independent judgment and exhibits strong attention to detail 

  • Good verbal, written and interpersonal skills 

  • Minimum 2-4 years related experience preferably in pharmaceutical (quaility) environment, manufacturing or FDA regulated industry  

  • Working knowledge of cGMPs Standards

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, and may be eligible for the Long Term Incentive 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.

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