Specialist Quality Assurance (JP7155)
Thousand Oaks, Ca
Electro-Mechanical Device External Supply
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.
* Must be able to work M-F, hours are flexible based on candidate schedule.
* Be Located or able to commute to Buffalo Grove, IL.
Our ideal candidate will have a bachelor’s degree in Mechanical Engineering or related field. Plus 5 years of relevant experience. Person-in-Plant (PIP) responsibilities include:
CONTRIBUTE TO THE MATURITY LEVEL AT AMGEN SUPPLIERS
- 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
Why is the Position Open?
- 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.
Supplement additional workload.
Top Must-Have Skill Sets:
Employee Value Proposition:
- 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.
Chance to work on communication and influencing skills with an outside vendor.
- Someone with short tenure.
- No bachelor's degree.
- Someone who is not able to work independently.
- No experience in a cGMP Environment.
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.