Sr. QC Analyst

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience's mission! Take a look at this opportunity with our Quality Control team, which is seeking a passionate individual, to fill the role of our Sr. QC Analyst. This role leads and provides expertise across multiple disciplines within the laboratory and provides method development/validation support.

This role is an entry level supervisory developmental role that will direct day-to-day staff activities including assignment of resources.

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world's leading hospital provider of 100% human milk-based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

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This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by:

• Subject Matter Expert in the following laboratory activities:
  • Testing of all incoming raw materials, raw milk, in-process, final container and stability samples in an accurate, efficient and timely manner
  • Performing environmental monitoring of manufacturing areas and utilities
• Support the development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
• Develop the necessary testing and criteria for the execution of validation studies and projects
• Provide technical solutions to challenges faced by the department that are imaginative, thorough, practicable, and consistent with organization objectives
• Frequent inter-organizational and outside customer contacts. Represent the organization in providing solutions to difficult technical issues associated with specific projects
• Write and review SOPs
• Provide data analysis and trending information to Quality Control team
• Provide subject matter expertise and leadership for the investigation and evaluation of non-conformances related to laboratory testing (OOS, NCs, LIRs, SOPs, CAPAs) and other investigations as necessary.
• Good documentation and investigation skills required
• Understand and follow Quality System Documents relevant to responsibilities and testing (e.g. SOPs)
• Supporting on all analytical activities
• Participate in self-inspections and regulatory inspections
• Understand and follow the Quality System requirements established by Prolacta Bioscience
• Drive department goals/objectives
• Manage and approve employee time sheets, overtime and paid time off
• On-going continuous improvement projects
• Prepare and deliver year-end reviews
• Perform daily team member check-in and respond to issues/requests.
• Perform Good Documentation Practices (GDP) checks on controlled forms.
• Training and cross-training of employees
• Be familiar with area SOPs and ensure standardized work processes and procedures are followed
• Respond to employee issues/requests
• Lead projects
• Direct day-to-day staff activities including assignment of resources - supervise others as assigned
• Able to perform supervisor duties and responsibilities when needed
• Facilitate and/or support Quality Control laboratory 5S; tour/audit ready at all times
• Assist management with team morale, metric reports, employee development, training, etc.
• Complete any other designated tasks, as necessary

• BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Chemistry or other applicable related fields; MS/PhD in technical field highly desired
• Minimum of 5 years with BS (3 years with advanced degree) in Pharmaceutical, Biological or Biotech industry; hands-on experience in manufacturing operations or pilot lab / scale-up operations; experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in protein chemistry/microbiology highly desired
• In-depth understanding and wide application of technical principles, theories and concepts in the field
• Demonstrated knowledge of Microbiology and Biochemical techniques and other related disciplines.
• Consistent use of best practices and knowledge of internal or external business issues to improve products or services
• Working knowledge of method validation according to ICH (International Conference of Harmonization) Q2(R1)
• Experience working in a laboratory that performs testing within a regulated environment
• Working knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred
• Must be capable of working in an FDA regulated environment
• Good documentation and investigation skills required

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