Quality Assurance

Integrated Resources Inc.; Groton (CT); On-site; USD 60,000 - 90,000; Full time

Job summary

A leading staffing firm is seeking a quality assurance professional to work within the Pharm Sci QA group. This role focuses on supplier management, quality communication, and ensuring that quality standards are maintained. The ideal candidate will hold a BS degree and possess knowledge of cGMP regulations, with previous experience in quality assurance supporting supplier management. Strong communication skills are essential, with the ability to handle multiple priorities in an evolving work environment.

Qualifications

• Minimum BS Degree or equivalent in a scientific discipline.
• Prior quality assurance experience supporting supplier management is desirable.
• Ability to shift priorities and tasks throughout the workday.

Responsibilities

• Perform duties within the Pharm Sci QA group associated with oversight of the supplier program.
• Responsible for regular communication of quality status and escalation of supplier-related quality issues.
• Review supplier documentation to ensure supply chain security.

Skills

Knowledge of cGMP

Supplier management

Risk-based supplier assessments

Professional demeanor

Communication skills

Education

BS Degree in a scientific discipline

Tools

SMS

M3

QTS

PDOCS

GDMS

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Job Responsibilities:

• 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 across the Clients network.

• 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 Clients MSQA group to provide updated supplier information

• 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

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