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Prolacta Bioscience · 3 days ago

Sr. QC Analyst

Duarte, CA

Full-time

Onsite

Senior Level

5+ years exp

Prolacta Bioscience is a privately held life sciences company dedicated to improving the lives of premature infants through innovative nutritional products. They are seeking a Sr. QC Analyst to lead laboratory activities, provide method development support, and manage day-to-day operations within the Quality Control team.

BiotechnologyHealth CareLife ScienceNutrition

Responsibilities

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

Qualification

Microbiology techniquesMethod validationLaboratory testingBiochemical techniquesDocumentation practicesData analysisLeadership skillsTeam managementCommunication skills

Required

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

Must be capable of working in an FDA regulated environment

Good documentation and investigation skills required