Cipla USA · 1 month ago
QA Inspector I - 2nd Shift
Cipla USA is a leading global pharmaceutical company dedicated to high-quality medicines. They are seeking a QA Manufacturing Inspector to monitor and ensure product quality throughout the manufacturing process, adhering to established specifications and SOPs.
Pharmaceuticals
Responsibilities
Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions
Conduct room and equipment checks (where applicable) 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 (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver the results to the QC Lab
Maintain records of standard weights and perform daily verification of balances
Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record
Monitor facility and product environmental operating conditions
Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions
Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step
Verify the functionality of all the 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 if applicable
Complete other duties or participate in project work as assigned by management
Qualification
Required
Minimum high school diploma
Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment
Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications
Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals
Effective interpersonal relationship skills and the ability to work in a team environment
Proficiency in the English language to include usage, spelling, grammar and punctuation
Must have current Good Manufacturing Practices (cGMP) knowledge
Must have strong attention-to-detail
Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed
Must have strong organization and communication skills (written, verbal, and presentation)
Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines
Preferred
Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred
Experience in MDI preferred
Company
Cipla USA
Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.