QA Compliance Lead

QA Compliance Lead

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

- Participating in the development and maintenance of quality systems, processes, and procedures to assure product quality and safety. - Assisting the quality assurance site manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities - Supporting risk management process throughout the product life cycle and providing senior management with key data from RA to help drive decisions. - Supporting, development, and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies - Assist in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. - Communicates and implements a strategy to ensure compliance - Responsible for review of batch records in support of disposition of bulk drug substance - Responsible for review of equipment validation protocols and report - General compliance quality systems management support for the following areas: - Raw material and solution release - Review of raw material specifications and solution docs - Release of single use disposable product to include label reconciliation - Review of temp. charts and docs or temp related excursions - Review and update label issuance and reconciliation process

General QA documentation support to include the following: - Issuance of batch records and issuance and tracking of log books, lab notebooks, and SOP binders - Scanning and filing of excursion docs and client related batch docs to support batch release - Develops process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc.

Qualifications

- BA degree or a min. of 5 years work exp. - 3 years exp working in a regulated industry - Demonstrated understanding or aptitude to understand drug or Pharma QMS requirements and regulatory requirements including but not limited to FDA, CFR 21 210 and 211 - Demonstrated exp. and proficiency with MS Office, word processing, spreadsheet (Excel), presentation, and database applications.