Quality Assurance Specialist III
This description is intended to be illustrative of the major duties to be performed.
General Description:
This position will report to the QA Compliance and Document Control Manager. The Quality Specialist III evaluates, tracks, trends, and monitors the Quality Assurance activities in an outsourcing facility. The position is responsible for final release review of batches including assessing and identifying trends to improve release processes. The position will support document control functions within Master Control. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites. The Quality Specialist III will also provide audit support as it relates to document control activities.
Essential Functions:
- Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met.
- Assist with monitoring the FMS system and generating FMS weekly report.
- Ensure that the required initial and continuing training of personnel is carried out and adapted according to need.
- Review and approve investigations of reprocessing/rework of products, analytical failures, and returns/salvages.
- Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
- Gather information from multiple departments for trending and presentation to management.
- Support internal and external audits from a document control perspective.
- Identify trends in the industry and recommend improvements.
- Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control.
- Assist with managing the document control system to ensure the integrity and accessibility of documents.
- Assist with implementing corrective actions related to document control findings from audits.
- Create and revise controlled documents, including but not limited to, SOPs, batch records, deviations, CAPAs, and change control.
- Write deviations as necessary.
- Assist with training of staff on document control processes and systems.
- Other duties as assigned.
Supervisory Responsibilities:
Experience and Necessary Skills:
Knowledge and experience with the cGMPs, preferably in a commercial compounding outsource facility.
Able to identify potential adverse issues.
Excellent organization and documentation skills.
Detail oriented.
Computer skills, including Microsoft Word and Excel.
BS or BA degree (in a scientific discipline desired).
3 or more years of relevant experience.
