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

The Quality Associate I is responsible for production compliance and support for all departments at Prolacta Bioscience within the regulated environment as applicable to state and federal regulation (i.e. FDA).

Primary Duties and Responsibilities

· Understand quality procedures, safety procedures and cGXP procedures and systems.

· Review in-process batch records/manufacturing run sheets to support Production.

· Conduct training for QA, QC, manufacturing, and milk bank departments.

· Identify and assess regulatory and quality risks in production and manufacturing according to applicable regulations and company quality practices.

· Write investigations, communicate, and report product quality problems in the production lines or anywhere in the facility to appropriate personnel.

· May work with suppliers on supplier issues, and completion of supplier corrective action report (SCAR).

· Investigate and write product complaints.

· Make limited interpretations of data generated and communicating the significance of these results to Quality Management.

· Support manufacturing teams in the investigation and prevention of non-conformance issues.

· Update procedures and process procedural changes.

· Quarantine incoming raw materials and review for manufacturing release.

· Support with internal/external GMP audits.

· Prepare Quality Metrics report for Monthly/Quarterly meetings.

· Perform GMP walk-throughs to ensure facility compliance.

· Act as a liaison between manufacturing and Quality to help trouble-shoot quality related issues.

· Assist with non-conformance investigations and training.

· Other duties as assigned.

Job Requirements and Qualifications

· B.A./B.S. Degree in Biology, Biochemistry, Chemistry, or other related sciences.

· 1-3 years of experience in a regulated manufacturing environment.

· Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 110 and 117 is highly desired.

· Strong written communication skills. Must be able to clearly document observation deviations.

· Excellent interpersonal skills to maintain partnerships between Quality and all departments to ensure the lines of communication are professional and congenial.

· Must effectively communicate with all levels of personnel.

· Must be flexible with hours to accommodate production/business needs.

• Ability to work in a cold environment for a limited period of time.

Other Knowledge, Skills and Abilities

· Working experience in clean room environment.

· Computer skills (i.e. MS Word, Excel, PowerPoint, etc.).

· Effective presentation skills.

· Working knowledge of continuous improvement a plus.

Work Environment (Location, travel, shift, on-call, etc.)

· Location: City of Industry to start and by the end of the year be dedicated to the Duarte office

· Travel: 5%

· Shift: Swing shift

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.