Sr Associate QA

Location: Thousand Oaks, CA
Date Posted: 02-16-2017
Title: Sr. Associate Manufacturing (NC/CAPA)
Job Summary:
Responsible for the execution of the nonconformance (NC) and corrective action preventive action (CAPA) processes in the Drug Product Supply organization. Staff member will be part of the Formulation, Fill, Inspection, and Testing team in B20. The individual will also be responsible for the management and execution of Class 2 and Class 3 NC/CAPA records for B31 DPA&P. The responsibilities include:
• Own Class 2 and Class 3 NC investigations across Drug Product Supply
• Ensure thorough and timely product impact and root cause investigations to deliver high quality investigations, prevent recurrence of issues, and support on-time disposition
• Provide coaching and mentoring to floor staff on NC Class 1 events
• Support the area NC trending program, working with the NC/CAPA Senior Manager and area subject matter experts to identify and execute preventive actions and CAPA Effectiveness Verifications
• Track and appropriately escalate NC/CAPA issues that could impact quality or timelines
• Lead cross-functional teams through causal factor analysis (CFA) and/or root cause analysis
• May present the NC/CAPA process and/or specific NC/CAPA records during internal and external audits/inspections
• Participate in Lean Transformation activities (e.g., Problem Solving, Error Proofing, SQDIP boards, Work Center Teams)
• Must comply with safety guidelines
• Must comply with cGMPs/CFRs which includes, but is not limited to, the maintenance of training records and written procedures.

Basic Qualifications:
• Doctorate degree
• Master’s degree and 3 years of operations or quality experience
• Bachelor’s degree and 5 years of operations or quality experience
• Associate’s degree and 10 years of operations or quality experience
• High school diploma / GED and 12 years of operations or quality experience

Preferred Qualifications:
• At least 10 years of biopharmaceutical and/or medical technology experience with increasing responsibility in the organization, including management experience
• A Bachelor's or Master's degree in Microbiology, Life Sciences or a related field
• Experience working in or supporting a Manufacturing environment or quality systems (e.g. NC/CAPA)
• Knowledge and experience with cGMP regulations, practices and compendia requirements pertaining to the manufacturing and testing of biopharmaceuticals
• Knowledge or experience with data trending, metrics generation, authoring protocols/reports, and authoring SOPs
• Knowledge and experience with Class 2 Nonconformance ownership
• Experience supporting Class 3 Nonconformances
• Experience working with internal or external audits
• Knowledge with processes involved in manufacturing and distribution, QA, QC, validation, and process development
• Ability to evaluate documentation/operations according to company procedures
• Possesses technical knowledge of DPA&P manufacturing processes
• Familiarity with Lean Transformation process and associated Operational Excellence tools
• Ability to drive decisions using the DAI model
• Capability to respond appropriately if a situation requires a different set of skills and work approaches
• Customer first mindset with the drive to understand internal and external customer expectations and requirements
• Capability to assimilate information and influence timely decisions that impact the functional area(s)

• Time Management
• Investigational and problem solving techniques
• Technical writing
• Strong communication and presentation capabilities (verbal and written) at all levels
• Statistical analysis tools to perform data trending and evaluation
• Negotiation
• Leadership

• Related manufacturing or quality systems experience in the biotechnology and/or medical device industry
• Leadership experience to drive investigations to closure
• Attention to detail and focus on quality of work
• Technical writing and investigation expertise
• Must be a team player
• Ability to organize work to handle multiple priorities and meet deadlines
• Must be flexible and adaptable to changing priorities and requirements
• Demonstrates understanding of when and how to appropriately escalate

"This posting is for Contingent Worker, not an FTE"
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