Compliance Associate II Jobs at Ohm Laboratories Inc. – New Brunswick, NJ, USA
Company: Ohm Laboratories Inc.
Position: Compliance Associate II
Location: New Brunswick, New Jersey, USA
Department: Quality / Compliance
Experience: Minimum 4 Years
Qualification: Bachelor's Degree
Travel: Up to 5%
Posted Date: August 15, 2026
Compliance Associate II – Job Overview
Ohm Laboratories Inc., a part of Sun Pharmaceutical Industries Ltd., is seeking a motivated and detail-oriented professional for the position of Compliance Associate II at its facility in New Brunswick, New Jersey, USA.
The position is focused on strengthening the site's Quality Management System (QMS), maintaining regulatory compliance, supporting inspection readiness and ensuring adherence to current Good Manufacturing Practices (cGMP).
The selected candidate will work closely with Quality, Manufacturing, Validation and Regulatory teams and will independently manage or support important quality-system activities, including deviation management, change control and cleaning validation.
Job Details
| Particular | Details |
|---|---|
| Company | Ohm Laboratories Inc. |
| Parent Company | Sun Pharmaceutical Industries Ltd. |
| Job Title | Compliance Associate II |
| Location | New Brunswick, New Jersey, USA |
| Department | Quality / Compliance |
| Experience | Minimum 4 Years |
| Education | Bachelor's Degree |
| Industry | Pharmaceutical |
| Travel | Up to 5% |
Key Responsibilities
Quality Systems Management
The Compliance Associate II will be responsible for supporting and managing various quality-system activities, including:
Independently performing preliminary assessments and managing deviations within TrackWise.
Reviewing and managing change controls.
Facilitating Change Review Board (CRB) meetings.
Monitoring deviation and change-control lifecycles to ensure timely investigation, approval, extension and closure.
Collaborating with cross-functional teams to complete quality events within established timelines.
Ensuring compliance with ALCOA+ data integrity principles across investigations, validation documents and GMP records.
Quality Metrics & Continuous Improvement
The role will also involve monitoring quality performance and identifying opportunities for improvement.
Responsibilities include:
Collecting and analyzing quality metrics related to deviations and change controls.
Trending quality data on a monthly, quarterly and annual basis.
Identifying recurring compliance risks and emerging trends.
Identifying opportunities for continuous improvement.
Escalating significant findings when required.
Recommending appropriate corrective and preventive actions.
Preparing quality summaries and presentations for Quality Management Reviews (QMRs) and leadership meetings.
Cleaning Validation Responsibilities
The selected candidate will support and oversee the site's Cleaning Validation Program.
Key activities include:
Maintaining the Cleaning Validation Program.
Developing and maintaining the Cleaning Validation Master Plan (CVMP).
Supporting initial cleaning validation activities.
Supporting periodic reviews and revalidation strategies.
Supporting continued verification activities.
Designing, reviewing and approving cleaning validation protocols and reports.
Conducting risk assessments related to cleaning processes and validation activities.
Evaluating worst-case product selection.
Reviewing swab and rinse sampling strategies.
Evaluating analytical methods and acceptance criteria.
Supporting the establishment and justification of MACO (Maximum Allowable Carryover) limits.
Assessing the impact of deviations, investigations and process changes on cleaning validation.
Audit & Regulatory Inspection Readiness
The Compliance Associate II will play an important role in maintaining the site's inspection readiness.
Responsibilities include:
Supporting FDA and regulatory inspection readiness programs.
Participating in mock inspections.
Supporting compliance assessments and gap analyses.
Supporting FDA inspections.
Supporting customer audits.
Participating in internal and corporate audits.
Coordinating documentation requests during audits.
Providing back-room support during regulatory inspections.
Supporting investigation reviews and other compliance-related projects.
Work Environment
This position involves working across office, laboratory and pharmaceutical manufacturing environments.
The role requires frequent interaction with Quality, Manufacturing, Validation and Regulatory teams.
The work environment may include:
Manufacturing and production areas
Laboratories and support areas
Office environments
Moderate workplace noise
Areas requiring personal protective equipment (PPE)
Physical Requirements
Candidates should be able to:
Stand, walk and sit for required periods.
Bend, stoop, kneel, crouch and reach as required.
Lift and carry up to 20 pounds.
Navigate office, laboratory, warehouse and manufacturing environments.
Wear required PPE such as safety glasses and safety shoes.
Travel: Up to 5%
Educational Qualification
Bachelor's degree is required.
Candidates with an educational background relevant to pharmaceutical sciences, quality assurance, chemistry, life sciences or related fields may be suitable depending on the employer's specific requirements.
Technical Skills Required
Candidates should have strong knowledge or experience in the following areas:
Quality Management Systems (QMS)
Pharmaceutical cGMP
Deviation Management
Change Control
Investigation Management
Cleaning Validation
Data Integrity
ALCOA+ Principles
Quality Metrics
Regulatory Compliance
Audit Readiness
CAPA
TrackWise or similar QMS platforms
Learning Management Systems (LMS)
Microsoft Excel
Microsoft Word
Microsoft PowerPoint
Microsoft Outlook
Data analysis and trending
Professional Skills
The ideal candidate should possess:
Strong project management and organizational skills.
Excellent written and verbal communication skills.
Strong presentation skills.
Good analytical and problem-solving abilities.
Strong decision-making capabilities.
Ability to manage multiple priorities.
Excellent attention to detail.
Ability to work independently.
Ability to collaborate effectively with cross-functional teams.
Proactive and self-motivated approach.
Continuous improvement mindset.
English proficiency at CEFR Intermediate B1+ level.
Experience Required
Candidates should have a minimum of 4 years of experience in a Quality Assurance role within the pharmaceutical industry.
Relevant experience includes:
Deviation management
Change controls
Quality investigations
Compliance programs
QMS management
Cleaning validation
Regulatory inspection readiness
Experience working in a global, multicultural or matrixed organization is preferred.
Who Can Apply?
This opportunity is particularly suitable for pharmaceutical Quality Assurance and Compliance professionals who have experience with quality systems and GMP compliance.
Candidates with practical exposure to deviations, investigations, CAPA, change controls, cleaning validation, QMS software and regulatory inspections may be well suited for this position.
About Ohm Laboratories Inc. & Sun Pharma
Ohm Laboratories Inc. is associated with Sun Pharmaceutical Industries Ltd., a global pharmaceutical organization with operations across multiple markets.
Sun Pharma has a significant presence in the United States and operates across specialty, generic and consumer healthcare segments. The organization focuses on pharmaceutical research, development, manufacturing, quality and regulatory compliance.
How to Apply
Interested and eligible candidates should verify the current vacancy and apply through the official recruitment channel of the employer.
Candidates are advised to review the eligibility criteria and job requirements carefully before submitting their application.
Official company career website:
Sun Pharmaceutical Industries – Careers
⚠️ Disclaimer
This job information is published by Helbert Solutions for educational and career-information purposes. Helbert Solutions is not the employer or recruitment agency for this vacancy and does not guarantee selection or employment.
Candidates should independently verify the vacancy, eligibility criteria, location, job requirements and application procedure through the official employer recruitment channel before submitting personal information.
