2nd shift: Monday-Friday, 3:15-11:45pm
We are seeking a detail-oriented and quality-focused IPQA Associate I to support in-process quality assurance activities across our pharmaceutical manufacturing operations. In this role, you will be responsible for monitoring manufacturing and packaging activities, ensuring compliance with cGMP requirements, SOPs, and quality standards, while helping to identify and address quality issues before they impact product integrity.
This is an excellent opportunity for a quality professional who enjoys collaborating cross-functionally, working directly on the production floor, and playing an active role in maintaining product quality and regulatory compliance.
- Perform routine area assessments to ensure compliance with cGMP requirements, SOPs, policies, and procedures.
- Provide line clearance authorization prior to manufacturing and packaging operations.
- Conduct conditional and final release inspections of packaging lines.
- Support and monitor in-process quality checks during manufacturing and packaging activities.
- Collaborate with Production and Packaging teams to resolve quality-related issues and ensure compliance throughout operations.
- Perform retain sample inspections as required.
- Support stability sample collection and submission to the Quality Control laboratory.
- Verify AQL (Acceptable Quality Level) inspections during batch manufacturing and packaging operations.
- Review and approve controlled documents, including manufacturing and packaging batch records.
- Ensure timely and accurate completion of quality-related documentation.
- Support the closure of immediate actions within TrackWise.
- Manage material status and compliance-related transactions within SAP.
- Review cleaning validation protocols and reports.
- Review process validation protocols and reports.
- Support Annual Product Review (APR) data entry and compilation activities as needed.
- Assist with quality improvement initiatives, remediation projects, and other QA-related activities.
- Maintain ownership and accountability for assigned QA processes and projects.
- Provide support across multiple New Jersey facilities as business needs require.
- Partner with Manufacturing, Packaging, Validation, and Quality teams to drive compliance and continuous improvement.
This role operates within a combination of manufacturing, laboratory, and office environments. The position requires regular interaction with production operations and quality systems to ensure compliance and product quality.
The work environment may include:
- Manufacturing and packaging operations
- Laboratory and warehouse areas
- Moderate noise levels
- Routine use of personal protective equipment (PPE)
- Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, and reach throughout the workday.
- Ability to lift and carry up to 25 pounds.
- Ability to navigate office, laboratory, warehouse, and manufacturing environments.
- Must be able to wear required PPE, including respirators, safety glasses, goggles, and safety shoes.
Travel: Up to 5%
- Bachelor's degree in a science related major required.
- Understanding of cGMP regulations and pharmaceutical quality systems.
- Experience with electronic quality systems such as TrackWise or similar QMS platforms.
- Proficiency with Microsoft Office applications, including:
- Word
- Excel
- PowerPoint
- Outlook
- Familiarity with SAP and Learning Management Systems (LMS) is beneficial.
- Knowledge of project management principles, practices, and tools.
- Ability to review and interpret validation documentation and manufacturing records.
- Strong organizational and time management skills with the ability to manage multiple priorities.
- Excellent verbal and written communication skills.
- Strong attention to detail and problem-solving abilities.
- Ability to work effectively both independently and within cross-functional teams.
- Self-motivated with a hands-on, proactive, and solution-oriented approach.
- English language proficiency at CEFR Intermediate B1+ level.
- Minimum 2 years of experience in a pharmaceutical quality role.
- Experience supporting manufacturing, packaging, quality assurance, or quality systems activities in a regulated environment.
- Experience working in a global, matrixed, or multicultural organization is preferred.
- Play a critical role in ensuring the quality and compliance of pharmaceutical products.
- Gain valuable exposure to manufacturing, packaging, validation, and quality systems.
- Work closely with cross-functional teams in a dynamic GMP environment.
- Participate in continuous improvement and compliance initiatives that directly impact product quality and patient safety.
- Build a strong foundation for career growth within Quality Assurance and Compliance.
If you are passionate about quality, compliance, and continuous improvement, we invite you to join our team and help ensure the highest standards of excellence across our manufacturing operations.
The presently-anticipated base compensation pay range for this position is $30.00/hr to $37.00/hr. 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.
