* Candidate Identified

Job Summary

Prolacta Bioscience Quality Control Method Development and Validation Senior Analyst is required to support method development and validation for methods used for testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling. In addition, the Quality Control Method Development and Validation Senior Analyst is required to support OOS (Out Of Specification), NC (Non-Conformances), LIR (Laboratory Investigation Report), contract laboratory support, and provide general quality systems support for the laboratory (i.e. SOP, CAPA etc.). This role is required to lead and provide expertise across multiple disciplines within the laboratory.

Primary Duties and Responsibilities

  • Subject Matter Expert of the following method development and analytical activities:
    • Development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
  • Preparation of experimental design, analytical method development and analytical method validation protocols and reports
  • Writing/reviewing of test specifications
  • Provide technical solutions to a wide range of difficult problems. Provide solutions that are imaginative, thorough, practicable, and consistent with organization objectives
  • Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects
  • Writing/reviewing of SOPs
  • Provide data analysis and trending

· 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, testing, e.g. SOPs
  • Completing any other designated tasks, as necessary
  • Participating in self-inspections and regulatory inspections
  • Understand and follow the Quality System requirements established by Prolacta Bioscience
  • Drive department goals/objectives
  • Assist managing and approving employee time sheets, overtime and paid time off
  • On-going continuous improvement projects
  • Assist in providing written feedback for year-end reviews
  • Training and cross-training of junior employees
  • Respond to junior employee’s issues/requests
  • Lead projects
  • May direct day-to-day staff activities including assignment of resources - no direct staff management

Job Requirements and Qualifications

· In-depth understanding and wide application of technical principle, theories and concepts in the field

· 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)

· 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

Qualifications

· BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Chemistry or other applicable related fields; MS/PhD in technical field highly desired

· Minimum of 6 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

Other Knowledge, Skills and Abilities

· Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.)

· Attention to detail

· Strong analytical and problem solving ability

· Self-starter and self-motivated, with the ability to work proactively using own initiative

· Ability to work independently and as part of a team

· Adaptability and a positive attitude

· Ability to multi-task

· Support/Lead various QC projects with the design, testing and implementation phases

· Hands-on approach, with a ‘can-do’ attitude

· 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.