Quality Assurance Specialist

Quality Assurance Specialist

IRI believes in commitment, integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.

Job Description

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.

Qualifications

• 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