Job Title: QA Coordinator
Salary: $55,000 - $58,000
Job Overview: Quality Assurance Coordinator is an integral member of the Quality Assurance/Regulatory Affairs department that is responsible for reviewing and approving production batch records and analytical records to meet company and departmental objectives. The Quality Coordinator is the lead and back-up support of the following systems:
- Batch Record Review
- Raw Material and Finished Product Release
- Analytical Data Review
- Laboratory Report Review
- Internal GMP systems audits
- Training Management (SharePoint LMS)
- Document Control System — Backup
- Controlled Document Issuance — Backup
- The Quality Coordinator will use site specific Electronic Resource Planning (ERP) systems and other systems to review and approve incoming raw material and finished product documentation and records. The position requires a thorough working knowledge of databases and computer software.
- The Quality Coordinator must possess a comprehensive knowledge of global management of change and change control notifications for clients/customers. This knowledge will be used to assess all documents reviewed to ensure compliance with all internal and external requirements.
- The Quality Coordinator must possess a comprehensive knowledge of ICH Q7, the industry’s cGMP standard and the relation of this guidance to production records.
- Operate in accordance and compliance with:
- Current cGMP regulations and ICH Q7 guidelines
- Cardinal Rules of Quality, Delivery and Safety
- Perform all of the duties and responsibilities of Quality Assurance Coordinator.
- Batch Record Review – Review and approve all applicable GMP records associated with the manufacture and release of Active Pharmaceutical Ingredients, Excipients, Food Additives, and fine chemicals.
- Batch record review and release of incoming raw materials, intermediates, finished products and cleaning procedures for all Excipient and API business. Working closely with manufacturing to ensure GMP/GDP practices.
- Analytical data package review as a part of batch record release.
- Log sheet reviews of all equipment used during product manufacturing.
- Ensure that manufacturing and laboratory personnel are properly trained for the tasks performed through training record review.
- Equipment utilized during manufacturing has been properly qualified / calibrated / validated.
- Data documentation and corrections to documentation are properly executed in compliance with cGMP Good Documentation Practices.
- Report Review – Participate in the review and approval of various laboratory reports.
- Method Development and Validation protocols and reports.
- Stability protocols.
- Reference standard qualification/requalification reports.Audits – Participate in and lead internal audits of Quality Systems in regard to cGMP. Participate in customer GMP audits of the facility.
- Review previous audit observations for the area being audited.
- Obtain/present/explain any data or procedural documents requested by the Auditor(s) associated with position.
- Identify and summon subject matter experts for assistance when necessary.
- Participate on the Internal Audit Team by performing system, process or procedural departmental audits according to the established internal audit schedule
- SharePoint LMS – Assist in the administration of the training system.
- Ensure that the necessary personnel updates and documents are added into the system.
- Enter QA/RA training records into the system.
- Maintain the accuracy of the data contained within the system.
- Corrective and Preventive Action (CAPA) — Work in coordination with the CAPA Coordinator in identifying and implementing deviations and investigations as needed to ensure proper compliance to GMP, Quality Agreements, Internal policies and procedures.
- Create/revise and review document change requests for SOP’s and PBR’s.
- Interact and communicate with manufacturing, supply chain, materials management, sales, engineering, process support/R&D, quality control and accounting on a daily basis to ensure awareness and compliance.
- Correspond with clients in regards to batch record release/review when necessary (i.e. Customer owned products).
- Bachelor's degree or equivalent experience and 2-5 years of experience in a GMP regulated industry. A degree in the Sciences is preferred.
- Computer skills - Microsoft Office software and databases.
- Working knowledge of the cGMP regulations (ICH Q7).
- Motivation and attention to detail are essential.
- Good observation, organization, prioritization and problem-solving skills.
- Must display the ability to lead teams and handle project management activities with supervision.