Documentation Specialist

Documentation Specialist

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

Contractor Role Description: Supplier Management

This Quality position is considered a global role reporting into the supplier management team within PharmSci QA who is responsible for supporting the Pharmaceutical Sciences R&D organization. The colleague will assist staff in managing supply chain security and performance of external parties who provide materials for GMP manufacturing.

Responsibilities:

Key responsibilities are expected to encompass the following:

• Perform a range of duties within the Pharm Sci QA group, associated with oversight and support of the supplier program (and may also support the external vendor inventory management function)

• Support efforts to introduce enhancements to the supplier program

• Responsible for regular communication of quality status and escalation of supplier-related quality issues, maintaining a close working relationship with Inventory Management, PharmSci QA and other sites

Specific Activities May Include:

• Review supplier documentation to support the creation of material supply channels and ensure supply chain security

• Interface with Inventory Management Personnel to obtain supply chain documentation

• Collect data to support completion of risk-based supplier assessments

• Interface with MSQA group to provide updated supplier information

• Update supplier tracking spreadsheets

• Research existing supplier audit reports and audit notices

• Execute QA review and release of routine and high priority transfer/shipment requests and packaging and ancillary components

• Execute extension of expiry dating

• Point of Contact for assessment of shipment damage

• Responsibilities may include occasional special project work and other duties as assigned by the department lead or site leadership.

Qualifications

• Minimum BS Degree or equivalent in a scientific discipline

• Knowledge of cGMP, including regulations related to supplier management programs is desirable

• Prior quality assurance experience supporting supplier management is desirable

• Experience using SMS, M3, QTS, PDOCS and GDMS is desirable

• Solid understanding of cGMPs as they relate to assigned tasks

• Professional demeanor exhibited through the proficient use of email and phone etiquette

• Ability to shift priorities and tasks throughout the workday to meet business requirements