Job 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.

Area 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

Work Conditions:

• Office Area
• Manufacturing floor
• Lab
• Warehouse

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, talk or hear, stoop, kneel, crouch or crawl
• Close vision
• Operate computer/office machines
• Gowning, wear safety glasses & gloves
• Lift up to 10 lbs.

Travel Estimate

Up to 5%

Education and Job Qualification

• Bachelor’s of Science 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

Experience

• 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)

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.

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