QA Batch Records Reviewer – Onsite NY (2nd Shift)

RXinsider LTD.; Hauppauge (NY); On-site; USD 66,000 - 86,000; Full time

Benefits offered by this job

401(k) matching

Health insurance

HSA

FSA

PTO - vacation/sick/flex time

Paid holidays

STD

LTD

Parental leave

Employee discounts

Job summary

Cipla is seeking a Quality Assurance Associate (Reviewer) for the Hauppauge, NY site. This on-site role focuses on reviewing batch production records to ensure GMP compliance and regulatory readiness.

The ideal candidate has a pharmacy or life sciences background and 2–3 years of QA experience, with strong attention to detail and cross-functional collaboration across departments. Competitive benefits and full-time hours are offered.

Qualifications

• Bachelor's degree in pharmacy, life sciences, chemistry, or a related field.
• Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry.
• Strong knowledge of GMP, regulatory requirements (FDA, EMA).

Responsibilities

• Review batch production records (BPRs) for completeness and compliance with GMP.
• Verify entries are signed and dated; resolve discrepancies before approval.
• Ensure documentation meets FDA/EMA regulatory requirements.
• Review, create and revise BPRs, SOPs and related docs.
• Assist audits by providing batch documentation and responding to queries.
• Suggest process improvements to speed up review and improve compliance.
• Conduct daily quality rounds on the shop floor to ensure GMP compliance.

Skills

Document management systems

Batch documentation analysis

Regulatory inspections

Organization and time management

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Tools

Master Control

Job description

Cipla is seeking a Quality Assurance Associate (Reviewer) for the Hauppauge, NY site. This on-site role focuses on reviewing batch production records to ensure GMP compliance and regulatory readiness.

The ideal candidate has a pharmacy or life sciences background and 2–3 years of QA experience, with strong attention to detail and cross-functional collaboration across departments. Competitive benefits and full-time hours are offered.