Job Summary

 

The Quality Associate I/II 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-through 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.

·         Review validation protocols and change control documentation (applicable for QA II).

·         Lead manufacturing teams in the investigation and prevention of non-conformance issues (applicable for QA II)

·         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 (applicable for QA I) or 2-5 years of experience in a regulated manufacturing environment (applicable for QA II).

·         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: Main location City of Industry

·         Travel: 5%

·         Shift: Swing shift


Direct Reports

 

N/A

 

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.