Company

Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.

Job Summary

Prolacta Bioscience Quality Control Compliance Analyst is required to support the regulatory compliance of the testing on incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling. In additionally, the Quality Control Compliance Analyst is required to support OOS (Out Of Specification), NC (Non-Conformances), LIR (Laboratory Investigation Report), contract laboratory investigations support, and provide general quality systems support for the laboratory (i.e. SOP, CPA, CAPA etc.). This role is required to work closely with and support each of these systems as they relate to the testing performed for Prolacta.

Primary Duties and Responsibilities

  • In-depth understanding and adherence to the Quality System requirements established by Prolacta Bioscience
  • Responsible for ensuring QC compliance with all Federal, State, local and Company regulations, policies, procedures and company guidelines related to Health, Safety and Environmental practices
  • Develop, maintain and report QC metrics and statistical analysis of QC data. Inform and work with Senior Management to address adverse trends.
  • Identify gaps in corporate practices, policies and procedures and facilitate the Company’s prioritization of work based on current regulatory environment, guides and regulations
  • Develop and implement systems to ensure inspection readiness
  • Work closely with and support OOS, NCs, LIRs, SOPs, CPAs, ORs and CAPAs for all testing that occurs within the Prolacta and contract laboratory for GMP production
  • Provide SME (Subject Matter Expertise) for the evaluation and conclusion of laboratory investigations
  • Provide the support required to generate installation/operation/performance qualifications for QC analytical instrumentation
  • Ensure QC instruments and equipment are calibrated and maintained
  • Understand and follow Quality System Documents relevant to responsibilities, testing, e.g. SOPs
  • Support for the training program as it pertains to the QC department
  • Support the development and execution of validation studies and research projects
  • Support/Lead various QC projects

Job Requirements and Qualifications

· Experience working in a laboratory that performs testing within a regulated environment

· Excellent documentation and investigation skills required

· Working knowledge of laboratory equipment troubleshooting, qualification, maintenance and calibration, required

· Statistical data analysis experience, preferred

· Knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred

· Excellent interpersonal, communication, presentation, and organizational skills

· 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

· Minimum of 4 years’ experience with BS (2 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 highly desired.

Other Knowledge, Skills and Abilities

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

· Attention to detail

· Ability to work independently and as part of a team

· Self-motivation, adaptability, and a positive attitude

· Ability to multi-task

· Project managements

· Ability to manage data and testing 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.