Quality Assurance Analyst II in Rancho Cordova, California at AMPAC Fine Chemicals

SK pharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities. We are looking for a Quality Assurance Analyst II to join our CA team. This position is in-office.

JOB SUMMARY

Quality Assurance is responsible for the issuance of controlled documents (batch records, work instructions and product labels) to support production, release and shipment of products. Production records are completed by Operations staff and are then submitted to Quality Assurance as evidence of the execution of an approved process or procedure (Batch record or work instruction). Once production records have been executed, reviewed by Quality Assurance and assembled into the complete record they are stored per standard procedures for eventual retrieval to meet various customer, regulatory or internal needs.

DUTIES AND RESPONSIBILITIES

• Issuance of controlled copies of batch records and work instructions to production.
• Issuance or review of original labels for use by production and shipping.
• Notify appropriate QA staff if an issue is observed that may require appropriate documentation and/or investigation and will work with the appropriate quality or production staff to resolve the issue.
• Be responsible for the timely review of records, to include confirming the completeness of the record and the accuracy of relevant entries against primary documents or sources, confirmation that calculations were completed correctly, Ensuring parameters of time, temp, pressure, etc. have been met based on the entries in the production record.
• Ensure the production records are completed in accordance with Good Documentation Practices. Communicate required corrections back to the production staff in a timely manner. Confirm any required corrections have been appropriately completed.
• Immediately notify the appropriate QA Specialist of any observations that might require investigation under a formal deviation.
• Release of equipment in accordance with reviewed production and testing records.
• Work with the relevant QA Specialist to release intermediates as needed to support the production schedule at AFC.
• Work with the relevant QA Specialist to support the release of final product.
• Assemble the completed record for scanning and storage.
• reconcile as appropriate the completed record with the issuance records.
• Scan, and bind as appropriate the completed records and place them into document storage.
• Be responsible for the organization and management of the QA document archive as appropriate.
• Complete document disposition letters when stored records are to be prepared for disposal or transfer to a customer as appropriate
• Be responsible to obtain and maintain appropriate training for the requirements of this role.
• All responsibilities are to be carried out in accordance with approved company procedures and the requirements of CGMP.

DISCLAIMER

May perform other duties as assigned.

EDUCATION AND EXPERIENCE

• An Associate’s degree is required for this position
• A Bachelor’s degree is preferred for this position.
• 6-9 years of relevant experience with an Associate’s degree.
• 3-5 years of relevant experience with Bachelor’s degree.

COMPETENCIES/SKILLS

• Strong attention to detail
• Ability to work in a fast pace, team-oriented environment
• Able to work independently when appropriate
• Able to act with a sense of urgency, while maintaining accuracy and data integrity
• General computer skills, working knowledge of Microsoft Office applications.
• Have a working knowledge of CGMP.

CERTIFICATIONS and LICENSES

• Not Applicable