What are the responsibilities and job description for the Pharmaceutical Quality Assurance Analyst position at APOCUS INC?
Overview
Join our dynamic team as a Pharmaceutical Quality Assurance (QA) Analyst and play a vital role in ensuring the highest standards of quality, safety, and compliance within our manufacturing processes. In this energetic and detail-oriented position, you will be responsible for implementing and maintaining robust quality systems, conducting thorough audits, and supporting continuous improvement initiatives. The Quality Assurance Analyst ensures the quality and compliance of materials, products, equipment, and processes across manufacturing operations. This role focuses heavily serving as the SME for the eQMS and eEMS systems, managing equipment, and supporting quality systems through owning the environmental monitoring and materials systems.
Responsibilities
Analytical Testing (FTIR):
- Perform routine and non-routine sample analysis using Fourier Transform Infrared Spectroscopy (FTIR).
- Interpret, document, and review FTIR spectra in accordance with internal specifications and regulatory guidelines.
- Support method development and validation for FTIR as required.
Quality System SME:
- Serve as Subject Matter Expert (SME) for eQMS, providing guidance, training, and troubleshooting support for all users.
- Maintain and update equipment records and calibration and maintenance schedules ensuring timely execution and compliance.
- Collaborate with cross-functional teams to implement and enhance digital workflows within eQMS, as needed.
Environmental Monitoring (EM) SME:
- Serve as Subject Matter Expert (SME) for eEMS, providing guidance, training, and troubleshooting support for all users.
- Act as SME for Sherpa, ensuring correct document management, revision control, and SOP adherence.
- Conduct evaluation of viable microbial samples and management of identification of recoveries internally or via 3 rd party.
- Review and interpret EM data to identify trends using the eEMS.
- Assist in investigations related to environmental excursions.
Incoming Materials Testing:
- Perform inspection and release testing for incoming materials, ensuring compliance with specifications and COAs.
- Document findings accurately and ensure timely disposition of materials.
- Support supplier and materials qualification processes.
Compliance & Continuous Improvement:
- Maintain compliance with GMP, GDP, FDA, and other applicable regulatory standards.
- Participate in internal audits, regulatory inspections, and quality events.
- Support CAPA, change control, and investigations.
- Drive continuous improvement initiatives within QC processes and quality systems.
- All other duties as assigned .
Reports to and supports the Quality Unit as directed
Pay: $25.00 - $30.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
Salary : $25 - $30