Responsibilities:
- Monitor and ensure product quality is maintained through all phases of manufacturing in compliance with established specifications.
- Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
- Perform room and equipment checks (where applicable) prior to each stage of manufacturing following detailed written procedures.
- Prepare in-process and finished product samples (where applicable) for QC lab, following detailed documentation procedures and delivering them to QC lab.
- Maintenance of standard weights and perform daily verification of balances.
- Monitor facility and product environmental operating conditions.
- Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions).
- Perform AQL sampling and inspections as required.
- Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
- Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
- Verification of functionality of all the equipment and associated controls during the batch run.
- Perform applicable testing and prepare report for customer complaints.
- Identify and report any non-conformances/discrepancies to management if applicable.
- High School Diploma/GED
- Prior experience in the pharmaceutical industry or quality. Knowledge of good manufacturing practices (GMP) and good documentation practices is preferred.
- Ability to read, write and communicate effectively.
- Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
- Excellent organization skills with the ability to focus on details
- Basic computer skills (Word and Excel)
- Good basic math knowledge and excellent attention to detail.
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.