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

  • Support 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 Quality System Documents relevant to responsibilities, testing, e.g. SOPs
  • Understand and follow the Quality System requirements established by Prolacta Bioscience
  • 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 Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, 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.

Direct Reports

None

 

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.


This position has been filled.