2 Senior Quality Control Manager - Med Device/Pharma Manufacturing Jobs in San Diego, CA
KP Recruiting Group is Hiring a Senior Quality Control Manager - Med Device/Pharma Manufacturing Near San Diego, CA
KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world’s leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements across the United States. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!
The Role:
Our client is seeking a talented Senior Quality Control Manager! The Sr Manager Quality Control is responsible for leading and managing the activities of the Quality Control department. The department consists of multiple groups focused on evaluating performance of products of several product lines and multiple scientific applications. Examples include flow cytometry, immunoassays, microscopy and cell imaging, and protein immunochemistry. Responsibilities include but are not restricted to the following: collaborate with R & D for new product transfer and consult to resolve issues with QC test strategies; collaborate with manufacturing, process engineering and QA for non-conforming product troubleshooting and resolution; develop strategy, organization, including process improvement to ensure the Quality Control meets business expectations.
Job Duties
Lead the activities for multiple functional QC teams. Responsible for all aspects of product quality.
Demonstrated to be highly proficient in all applicable QC techniques, relevant equipment and software packages associated with testing, data analysis and interpretation, and data reporting. Works with supervisors and team members to meet QC sample schedules and resolve any technical problems.
Works with R & D for new product transfer, new technique training and capacity planning etc.
Work with manufacturing and process engineering to identify and resolve problem areas in reproducible production of existing products.
Work with technical service to help resolve customer complaints
Manage multiple projects and functional departmental groups to analyze and solve complex and challenging problems in reagent operations.
Develops and implements business strategies to achieve objectives.
Assist and mentor associates to develop skills and techniques Provide guidance to experimental strategy, problem characterization, data acquisition and analysis.
Ensure products meet quality and regulatory standards Lead and work with multi-functional teams to identify, evaluate and implement improvements and new technologies that will boost product quality, yields and reduce production costs.
Apply lean and six sigma practices into the development, scale up and setup of the manufacturing processes.
Review development activities, validation protocols and reports for manufacturing equipment and processes.
Requirements
A minimum of 3 years of experience in managing a multi-functional group in quality control, process development or R&D.
A minimum of 8 year experience in a FDA or ISO regulated production environment is preferred
Requires a minimum of a Bachelor degree.
15 years of experience in biological sciences or related field or an advanced degree and 10 years of experience in biological sciences is preferred
Assets:
Attention to detail and willingness to be “hands on” to achieve project objectives
Project management experience
Effective in collaborating and managing within a matrix managed organization
Effective interpersonal and leadership skills
Experience with organic chemistry
Knowledge of methods for protein purification, conjugation to fluorochrome and haptens, flow cytometry, immunochemical and immunoassay techniques highly desirable
Knowledge of general laboratory safety, GMP's and associated regulatory requirements
6 Sigma or Lean Manufacturing certification is preferred
Knowledge of statistics and its application in product and process optimization
Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
Experience with SAP
Benefits
- 401k Matching
- Family and Individual Insurance Packages (Health, Life, Dental, and Vision)
- Paid Time Off & Paid Holidays
- Long & Short-Term Disability
- Identity Theft Plans
- Retirement & Pension Plans
- Employee Assistance Program
- Employee Referral Program
- Tuition Reimbursement Programs
- Advancement & Professional Growth opportunities
- Parental Leave
- & More
Job Summary
Full Time
Business Services
$117k-149k (estimate)
03/09/2024
05/08/2024
kprecruiting.com
Minneapolis, MN
<25
Business Services
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