The Quality Assurance Specialist - Documentation role is responsible for ensuring that all documents related to manufacturing within the Clinical Manufacturing Facility are in compliance with Good Manufacturing Practices (cGMP) regulations, policies and procedures. This position reports to the QA Supervisor and will work closely with Andelyn Biosciences staff.

 Under the guidance and direction of the Quality Assurance Change Control/Operations Supervisor, essential functions of the Quality Assurance Specialist - Documentation:

Business Architecture:

• Maintain compliance with applicable regulatory and requirements for cellular and gene therapy products.
• Coordinate the timely revision, review, approval and management of GMP documents, including.

           o      Maintenance of the databases/spreadsheets and keep up to date with tracking of change control records, deviation records, CAPA records and other documentation as required.

o   Assign document numbers, as required via the systems in place.

o   Upload completed documents to Training Management system and other systems, as required.

o   Assignment of Master Batch Record ID numbers and issuance of Batch Records and related forms for execution.

o   Works with the Operations team to track batch records throughout their lifecycle.

o   Reconciliation of batch records after they’ve been executed. 

• Act as a liaison between the QA and other departments to facilitate documentation revisions, implement Change Controls or CAPAs and to help identify potential issues
• Assist the QA Change Control/Operations Supervisor with identifying areas for quality improvement and the development of action plans and metrics needed to monitor progress toward meeting quality improvement objectives.
• Provide additional support as directed by Quality Assurance Management.
• Responsible for reporting any deviations to procedures, specifications or systems to the Supervisor with logic, data and possible corrective measures.
• Accountable for working with problems associated with a wide variety of quality issues that could range from errors in production, incomplete batch records, component re

  

Knowledge, Skills and Abilities required

• Bachelor’s degree in a scientific related discipline, or 10 years of GMP experience.
• Minimum 4 years’ experience in the pharmaceutical industry in Quality Assurance or Quality-related department.
• Minimum 1 years’ experience in working with GMP documentation 
• Excellent communication skills, both written and verbal, in combination with strong interpersonal skills and demonstrated technical writing skills.
• Excellent detailed knowledge of cGMP, GLP, FDA guidelines.
• Ability to work in a fast-paced environment and prioritize workload.
• Proficiency with applicable software (Trackwise, Microsoft Office, etc.) preferred
• Travel requirements: 10%

 

 Minimum Physical Requirements

• Sitting (Constantly)
• Talking on the phone/in person (Constantly)
• Typing on a computer keyboard (Constantly)
• Standing/walking (Occasionally)
• Lifting 45 lbs or greater (Frequently)                                                                                             

 

EOE M/F/Disability/Vet