QA Specialist IV
• Key responsibilities:
o Performs batch record and SOP reviews to ensure cGMP activities are completed and documented in accordance with internal SOPs and regulatory requirements.
o Performs auditing of documentation generated during manufacturing processes and for ancillary areas of manufacturing, coordinating of review and any follow-up action or corrections of GMP documentation.
o Auditing documentation generated from the Quality Control department and the Analytical Laboratory.
o Write/assist with quality related investigations.
o Update current forms into an EPS format.
o Update current SOPs into an EPS and DMS format.
o Maintain accurate records and documentation.
o Upload documentation to DMS and set approval workflows within DMS. Developing ability to interpret and apply cGMP regulations.
o Provide administrative support for metrics management.
o Perform other business critical duties when necessary as determined by management
o Associates degree or equivalent years of experience working in a GMP industry is preferred.
o Experience in working in the Quality Assurance department in a regulated industry.
o Computer Software skills, record keeping, detail orientated and thorough.
o Experience with TrackWise and Documentum a plus.
o Basic understanding of cGMP regulations and general knowledge of manufacturing processes.
o Shows initiative and is skilled in prioritizing workload in a busy manufacturing environment.
o Ability to work independently.
o Ability to lift up to 30lbs.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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