QA Specialist II
Billerica, Massachusetts
- Full Time
- Level: Entry
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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.
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Career Growth
Get support for your career growth and development.
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Benefits Programs
Discover comprehensive benefits to support the health and wellness of you and your family.
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Time Off
Enjoy paid time off and leave-of-absence options.
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Compensation
Earn competitive compensation with incentive programs that reward our shared success.
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Working Conditions
Work confidently in the safe, clean, and regulated work environment that we foster.
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Team Environment
Collaborate in a workplace that’s rooted in our values and encourages cross-team engagement.
QA Specialist II
Billerica, MassachusettsJob Summary:
Executes all activities involving quality assurance and compliance utilizing Current Good Manufacturing Practices (cGMP) requirements for pharmaceuticals and medical devices. Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and/or clinical products.
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 (manufacturing) environment, Quality Assurance, Quality Control and/or production, or FDA regulated industry
Working knowledge of cGMPs Standards
Experience in pharmaceutical environment (manufacturing and/or Quality)
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