Title: QA Specialist II

Date: Sep 19, 2025

Location: Sun - Billerica - Plant

Company: Sun Pharmaceutical Industries, Inc (USA)

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.