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Development Quality Assurance Specialist II

Billerica, Massachusetts

Category Development Job ID R-50999

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Job Purpose

The Specialist Quality Assurance is responsible for providing support to the Quality Assurance department.
This role will work with cross-functional teams to maintain internal Quality Systems.

Key Roles and Responsibilities

Assist in the execution of Quality Systems to support GLP, GMP and GCP, including both internal and external work
Support internal GxP activities
Administer, follow-up, write, review and approve Quality System documentation (deviations, investigations, CAPA)
Review and help approve all GxP documentation including master batch records, labels, protocols, forms, stability data and reports
Assist with tracking and trending of Quality System metrics (deviations, investigations, CAPA, etc.)
Write, review and approve SOPs and Forms
Help to maintain equipment related to GMP testing and manufacturing
Help maintain Quality’s Supplier Qualification Program
Help maintain other GxP programs as needed
Assist with internal and external audits as needed

Qualification, Skill and Competencies Requirements

BA/BS in Life Sciences
Minimum of 2 years GxP experience
Strong knowledge of MS Word and Excel
Excellent written and verbal communication skills
Must be able to work both independently and in a team situation

The presently-anticipated base compensation pay range for this position is $95,500 to $106,000. 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.

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About Us

Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the eighth-largest generics pharmaceutical company in the U.S., and we are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology, and oncology as key target segments.

Our Values

Sunology, a combination of Sun and Ideology, is the way of life at Sun Pharma. We practice humility, integrity, passion, and innovation.

How We Work

With people at our core, Sun Pharma has built an inclusive and collaborative work culture, where all employees are empowered to pursue their dreams and professional aspirations.

Create Your Own Sunshine

Create Your Own Sunshine

At Sun we empower our employees to be Better Everyday, Take Charge and Thrive Together.

Benefits

Health & Wellness

We offer comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
Financial

We provide a competitive 401(k) match program and financial wellness programs to support our employees’ short- and long-term financial goals.
Life, Work & Family

We provide work-life benefits that support our employees beyond their workday.