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Qaulity Associate II

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POST DATE 9/16/2016
END DATE 10/16/2016

Prolacta Bioscience, Inc. City of Industry, CA

City of Industry, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #


Job Summary

The Quality Associate II is responsible for production compliance through all stages of the manufacturing process adhering to FDA Regulation. Duties and Responsibilities Understand quality procedures, safety procedures and cGMP procedures and systems.

* 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.

* 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.

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

* Review validation protocols.

* Lead 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. Perform/assist 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 QA to help trouble-shoot quality related issues.

* Assist with non-conformance investigations and training. Other duties as assigned.


* S. Degree in Biology, Biochemistry, Chemistry, or other related.

* 2-5 years of experience in a regulated manufacturing environment.

* Aseptic filling/clean room experience preferred.

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

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

* Excellent interpersonal skills to assists in maintaining a partnership between Quality and Operations 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 needs.


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.