Analytical Quality Assurance Analyst I
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 following 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 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.
Requirements - 3 years' experience in a quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
- 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 or parentals preferred.
- 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.
- Must have current Good Manufacturing Practices (cGMP) knowledge.
- Must have strong attention-to-detail.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.