Job Summary
Prolacta Bioscience Quality Control Method Development and Validation Analyst is required to support method development and validation for methods used in testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling. In addition, the Method Development and Validation Analyst is required to support OOSs (Out of Specification), NCs (Non-Conformance), LIRs (Laboratory Investigation Report), ORs (Observation Report), CAs (Corrective Action) and/or CAPAs (Corrective and Preventative Action), and contract laboratory investigations.
Primary Duties and Responsibilities
• Development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
• Support the preparation of experimental design, analytical method development and analytical method validation protocols and reports
• Writing/reviewing of test specifications and SOPs
• Frequent inter-organizational and outside customer contacts
• Represent the organization in providing solutions to difficult technical issues associated with specific projects
• Support data analysis and trending
• Support 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 the Quality System requirements established by Prolacta Bioscience
• Understand and follow Quality System Documents relevant to responsibilities, testing, e.g. SOPs
• Participate in self-inspections and regulatory inspections
• Drive department goals/objectives
• Support On-going continuous improvement projects
• Complete other designated tasks, as necessary
Job Requirements and Qualifications
• BS in Microbiology, Biochemistry, Chemistry or other applicable related fields
• Minimum of 2 years with BS (1 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.
• Working knowledge of method validation according to ICH (International Conference of Harmonization) Q2(R1)
• Excellent interpersonal, communication , presentation and organizational skills
• 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 a FDA regulated environment
Other Knowledge, Skills and Abilities
• Strong analytical and problem solving ability
• Adaptability and a positive attitude
• Ability to work independently and as part of a team
• Attention to detail
• Ability to multi-task
• Self-starter and self-motivated, with the ability to work proactively using own initiative
• Support various QC projects with the design, testing and implementation phases
• Hands-on approach, with a ‘can-do’ attitude
• Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.)Ability to enter and manage data within a LIMS system
Work Environment (Location, travel, shift, on-call, etc.)
This position is required to support testing at both the City of Industry and Duarte Prolacta locations. Travel (car) between locations may be required. Up to 10% travel may be required.
Physical Requirements
This position requires working in a laboratory setting for an 8 hour shift. Laboratory testing includes the handling and disposal of hazardous materials. Office work will also be required for the analysis/reporting of data, writing/reviewing of reports and SOPs.
a. Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.
Amount of Time
Activity None Up to 1/3 1/3 to 2/3 2/3 or more
Stand X
Walk X
Sit X
Talk or hear X
Use hands to finger, handle or feel X
Climb or balance X
Stoop, Kneel, crouch or crawl X
Reach with hands and arms X
Taste or smell X
b. Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.
Amount of Time
Activity None Up to 1/3 1/3 to 2/3 2/3 or more
Up to 10 pounds X
Up to 25 pounds X
Up to 50 pounds X
Up to 100 pounds X
More than 100 pounds X
Direct Reports
None