Must Haves:
- Investigation Experience
- Pharma Background Strongly Preferred
- Regulatory Experience within Technical Writing Strongly Preferred
Summary:
- The position will conduct root cause investigations, close deviations, support assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
- Perform calculation, data collection in support of QC lab site, global CI initiatives, and management reviews. Participate in the development and technical writing of documentation for the validation of equipment and required to support testing of the Los Angeles Manufacturing Facility. Lead and/or drive completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned. May function as a backup Supervisor. Ensure that the daily operations of assigned functional area are met through scheduling, troubleshooting and coaching.
Essential Duties and Responsibilities:
- Support and/or lead continuous improvement projects such as Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it’s, VIPs using Lean/DMAIC concepts and philosophy.
- Assist Compliance Supervisor in leading daily operations to ensure coordination and efficiency.
- Participate in the generation of test plans, protocols, and reporting documentation for the validation of equipment supporting testing of the LA Facility.
- Perform review of test data with application of GDP.
- Use Global LIMS or other computerized systems for entering, approving, and trending test results.
- May be required to conduct investigations and/or audits into Alert/OOL excursions.
- Actively contribute to a team setting at the Los Angeles Manufacturing Facility and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.
- Provide training and work direction for assigned functional areas.
- Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
- May be required to generate, execute, and/or summarize studies and/or review/revise of SOPs. Complete and/or direct completion of special project/protocol testing in a timely manner.
- Assist Compliance Supervisor in updating department metrics and report shift activities, as assigned.
- Ensure personal training requirements are met and that training records are current.
- May perform disposal of hazardous waste.
- Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management.
- Lead and/or facilitate problem solving events. Lead the investigation closure of manufacturing compliance related documents. Using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance.
- Represent the departments during the product release process, compliance, and Continuous Improvement projects and audits.
- Participate in deviation related meetings and provide feedback, leadership, and support to manufacturing supervisors, trainers and manufacturing technicians on the status of compliance of the department.
- Conduct mediations to ensure timely release of product for customers. Assist in meeting product release time goals.
- Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
- Identify and implement process improvement and Value Improvement Projects (VIP) to drive success in the areas of compliance, throughput, workplace safety, cost effectiveness, and product lead time.
- Participate in regulatory and non-regulatory audits
- Other duties as assigned.
Job Requirements:
Qualifications:
- Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
- Effective organizational skills and ability to plan and suggest resolutions to technical problems.
- Demonstrated working knowledge of assays/equipment in functional area.
- Must be detail-oriented, conscientious, and responsible.
- Capable of applying some decisions-making to problem-solve technical, compliance, or operational problems, as assigned.
- Effective interpersonal communication. Must have effective verbal and written communication skills.
- Can demonstrate the ability to guide people, encourage teamwork, and teach.
- Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.
- Good project management skills a plus.
- Must be able to learn new computer systems and programs in a timely manner.
- Demonstrate interpersonal skills with the ability to interface and influence with personnel of all levels and participate effectively and efficiently in a team environment.
- In-depth process knowledge of related manufacturing equipment and processes.
- Ability to analyze and interpret scientific and statistical data.
- Experienced understanding of cGMP and other regulatory guidelines applicable to the medical/bio-tech industry.
- Lead investigation and provide comprehensive investigation write up and/or presentations
- Working knowledge of Quality Systems
- Good computer skills and working experience with Microsoft Office applications
Education:
- Typically requires bachelor’s degree in chemistry, biological science, or other related technical field. 2+ years of related experience.
Physical Demands:
• Must be able to lift, push, pull and carry up to 25 lbs and push up to 50 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Working Environment:
• Must be able to work in controlled environments and cool/hot storage conditions requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will be working in a loud area that requires hearing protection and other protective equipment to be worn.
• 20/20 near vision required (corrected vision is acceptable)
• Will work in a cold, wet environment
• Will work around chemicals such as alcohol, acids, and alkalines that requires protective equipment
• May be required to work or be assigned to a different shift as needed.
• Must be able to work overtime as required.
• May be required to work in a confined area. Inside and Outdoor working conditions.
• Perform removal of hazardous waste.