Quality Assurance Specialist

Summary-

• Accountable for activities involved in Quality oversight for review and release of finished goods, raw materials, and packaging components, issuance of master batch records and associated documentation, and tracking of investigations, change controls, and action items as they relate to material release activities.

• Maintains routine programs and processes to ensure high quality product and compliance with current cGMPs

• Must be familiar with all aspects of the manufacturing and quality operations

• Ability to effectively prioritize and manage a varied workload is an essential function of this position.

Role Responsibilities-

• Support Manufacturing batch record review activities

• Prepare and issue Production Batch Records

• Perform review and release activities related to finished goods, raw materials, and packaging components

• Assist in the development and implementation of QA systems and SOPs

• Initiate and assist in Quality Investigations of cGMP products as required

• Generate Incident Reports, Change Controls and CAPA reports as required

• Perform initiation, maintenance and closure activities of Quality Assurance Operations systems such as Discrepancies, CAPAs, and Change Control to support QA operations and ensure compliance with SOPs

• Identify, investigate, and prepare reports on quality issues

• Interpret generated data and communicate results to Quality Management

• Maintain effective communication and partnership with Operations department and Materials Management

• Maintain relevant training

• Perform additional assignments as directed by the Quality Assurance Manager.

• AS/BS/MS in any science or technology related field with relevant industry experience

• Experience with filing batch records is required or preferred

• Experience with supporting manufacturing batch records

• High school diploma or 1-3 years of related pharma experience is required but not preferred

Thanks

Regards

Ricky

732-429-1925