Job Title: Specialist Quality Assurance / Medical Device (JP7051)
Location: Illinois, Chicago/Buffalo area, 62706
Employment Type: Contract
Business Unit: Electro-Mechanical Device External Supply
Duration: 6+ months (with likely extensions)

3 Key Consulting is hiring a Specialist Quality Assurance for a consulting engagement with our client, a leading global biopharmaceutical company.

Job Description

** Must be able to work M-F, hours are flexible based on candidate schedule **
** Be Located or able to commute to Buffalo Grove, IL**

Ideal candidate- Bachelors Degree in Mechanical Engineering or related field, plus 5 years of relevant experience

Contribute To The Maturity Level At Company Suppliers

Person-In-Plant (PIP) Roles and Responsibilities:
Ensure successful execution of cGMP compliant manufacturing activities at suppliers according to the Quality Agreement approved by Amgen and through knowledge of agency expectations and compliance with regulations.
Review production readiness, identify/monitor improvement opportunities, and assist in on-site investigations as needed.
Represent Amgen at the supplier’s manufacturing operations to ensure error-proof production activities.
Confirm suppliers material management readiness.

MONITOR AND IMPROVE THE SUPPLIER PERFORMANCE AND RISK SURVEILLANCE
Build a good understanding of supplier’s raw materials, molding (experience a plus), assembly and processing equipment.
Proactively engage in the production steps to obtain working knowledge of floor challenges / support needed.
Assess risk by the active collection of feedback on supplier performance. Input to be incorporated into supplier oversight practices.
Communicate issues/updates/decisions on key deliverables and activities throughout the manufacturing process (including pre and post) -Engage Amgen core team members/Management as appropriate.
Prior to any run -evaluate site production readiness to ensure success.

Enhance Cross Company Communication & Relationship
Ensure immediate assistance on site in case of any unexpected event.
Support triage of investigations and/or deviations to ensure communication and acceptable mitigation strategies.
Provide updates/summary reports to Amgen team at a minimum of weekly (past highlights/lowlights, forward looking).
Be present at suppliers site for unit operations and review documentation as deemed necessary
During the run – be engaged in production progress and identifying early warning signs and suggest corrective actions real-time.

Please note that the main role of this person is on-the-floor manufacturing Quality Assurance support. This person will NOT be responsible for managing metrics, change control, deviation or sample plan records, project management, or extensive tracking.

Degree in Chemistry, Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Engineering (or Technology) and Biology or related technological field

Top Must-Have Skill Sets
Quality Assurance experience with cGMP production environments; direct work experience with cGMP processes involved in manufacturing
Understanding and proven real-life application of regulations in a cGMP Environment
Strong interpersonal skills; comfortable communicating with both internal team and external clients

Employee Value Proposition

Chance to work on communication and influencing skills with an outside vendor

Red Flags
Someone with short tenure
No bachelor’s degree
Someone who is not able to work independently
No experience in a cGMP Environment
Interview process:
phone and in person near Chicago or Buffalo Grove, IL

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