QA Inspector I - 2nd Shift

Local applicants only – not for global assignments or employees working outside of Cipla's U.S. subsidiaries or affiliates.

About the role

The QA Manufacturing Inspector monitors and ensures product quality throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs). This role is an individual contributor position within the InvaGen Pharmaceuticals Plant Quality Team, reporting to the Manager of QA and may be matrixed to other functional leaders within Quality or other departments.

Responsibilities

• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Conduct room and equipment checks prior to each stage of manufacturing by following detailed written procedures.
• Execute acceptable quality limit (AQL) sampling and inspections as required.
• Inspect in-process and finished product samples for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver results.
• Maintain records of standard weights and perform daily verification of balances.
• Ensure proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review engineering records such as temperature and humidity data calibration, PM records, pest control records, and contractor-related functions.
• Assess online batch records for completeness of signatures, entries, and actual reconciliation/yields prior to initiation of the next processing step.
• Verify the functionality of all equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management.
• Complete other duties or participate in project work as assigned by management.

Requirements

• Minimum high school diploma.
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or a related field from an accredited college/university is preferred.
• Minimum of two (2) years’ experience in quality assurance in a GMP pharmaceutical manufacturing operation.
• Experience in MDI preferred.

Skills

• Proficient in personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• Ability to influence decision-making and facilitate completion of work toward business goals.
• Effective interpersonal relationship skills and ability to work in a team environment.
• Proficiency in English (usage, spelling, grammar, and punctuation).
• Current Good Manufacturing Practices (cGMP) knowledge.
• Strong attention-to-detail.
• Self-starter with initiative to seek additional training or direction as needed.
• Strong organization, communication (written, verbal, and presentation), and multitasking skills.
• Detail-oriented with the ability to prioritize tasks under strict deadlines.

Pay

$23 – $30 per hour.

Schedule

Second Shift: 3:00 PM – 11:30 PM (may vary based on business needs).