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Quality Assurance Analyst I

4 months ago

Rancho Cordova, United States AMPAC Fine Chemicals Full time
Job DescriptionJob Description

SKpharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities located in California, Texas, and Virginia specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities. We are looking for a Quality Assurance Analyst I to join our team at our Rancho Cordova, CA location. This is an on-site position.

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. The Quality Assurance Analyst I has the responsibilities described below as they relate to the support of manufacturing, equipment cleaning, product release and document control. Work is closely supervised.

DUTIES AND RESPONSIBILITIES

  • Issuance of controlled copies of batch records and work instructions to production.
  • Issuance of original labels to production and shipping. These labels will be issued only once required secondary review has been completed.
  • communicate with the appropriate requestors the timeline and status of controlled document requests.
  • Notify appropriate QA staff if an issue is observed that has the potential to impact quality 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. Any required corrections will be confirmed to have been appropriately completed.
  • Immediately notify the appropriate QA Specialist of any observations that might require investigation under a formal deviation (Variance).
  • Release of equipment in accordance with reviewed production and testing records.
  • 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 archive.
  • Complete document disposition letters when stored records are to be prepared for disposal or transfer to a customer.
  • 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 AFC procedures and the requirements of cGMP.

REQUIREMENTS

EDUCATION AND EXPERIENCE

  • Typically requires 0-1 years of related experience and a bachelor's degree or equivalent experience.
  • An Associate’s or Bachelor’s degree is preferred for this position.
  • 3-7 years of relevant experience with an Associate’s degree.
  • 1-3 years of relevant experience with Bachelor’s degree.

COMPETENCIES/SKILLS

  • Ability to work in a fast pace, team-oriented environment.
  • 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.
  • Strong attention to detail.

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at this time.