Quality Associate II

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience's mission! Take a look at this opportunity with our Quality Assurance Department which is seeking a passionate individual, to fill the role of Quality Associate II.

The Quality Associate 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).

Who Is Prolacta Bioscience?

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world's leading hospital provider of 100% human milk- based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

For more information, please visit www.prolacta.com.

How You Will Contribute

This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by...

• Understand quality procedures, safety procedures and cGxP procedures and systems.
• Conduct cross functional training for any applicable departments.
• Support investigations for donor lookbacks, recalls and perform annual mock recall activities.
• Identify and update procedures that require corrections or updates.
• Review and may approve the following records in the quality system: CPAs, CSRs, LIRs, ORs, NCs, CAPAs, PCs, Risk Assessments, Planned Deviations and CCRs.
• Identify and assess regulatory and quality risks in operations according to applicable regulations and company quality practices. This could include on floor observations and support.
• Communicate and report product quality problems in the production lines or anywhere in the facility to appropriate personnel.
• Write and provide technical review for observation reports (OR), nonconformance (NC) or CAPA investigations and determine effective corrective actions.
• May work with suppliers on supplier issues, and completion of supplier corrective action report (SCAR).
• Review preventative maintenance forms.
• Support annual product review initiatives.
• Support recalls / field corrective actions.
• Support non- medical and medical product complaints.
• Make interpretations of data generated and communicating the significance of these results to Quality Management.
• Review and support the change control process. This may include reviewing Change Plans and processing tasks and extensions.
• Lead or participate in risk assessments.
• Interface with the Manufacturing Enterprise System and conduct Quality tasks.
• Identify, lead and support continuous improvement initiatives (i.e. kaizens, just do it projects, etc.).
• Identify and update procedures that require corrections or updates.
• Quarantine incoming raw materials and review for manufacturing release.
• Perform/assist with internal/external GMP audits.
• Prepare Quality Metrics report for Monthly/Quarterly meetings and gather weekly metrics data.
• Perform EHS and GMP walk-throughs to ensure facility compliance.
• Act as a liaison between Operations and Quality to help trouble-shoot quality related issues.
• Review and complete Milk Bank discrepancies and disposition raw milk and donors.
• Support IT System validation execution through test scripts.
• Provide support to all departments requiring assistance. This may include Research and Development (R&D) requests that pertain to batch records or product movement between facilities.
• Provide training to co-workers regarding Quality Associate responsibilities.
• Daily Production and QC floor support
• Lead manufacturing teams in the investigation and prevention of non-conformance issues.
• Review validation protocols and change control documentation.

• Review in-process batch records/manufacturing run sheets and COAs to support product release.
• Other duties as assigned.

What You Bring to the Role

• B.A./B.S. Degree in Biology, Biochemistry, Chemistry, or other related sciences.
• 2-5 years of experience in a regulated manufacturing environment.
• Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 11 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.

How Prolacta Benefits You

To drive the personal growth and business impact of our employees, we're committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage starting on the first day of the month after your first day and 401(k) match, we value our employees' health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities.

What Else Do You Need to Know

• Location: Main location Duarte, with flexibility to support City of Industry as needed
• Travel: 5%
• Shift: Day shift

Depending on your residential location certain laws might regulate the way Prolacta manages applicant data. California Residents, please review our Privacy Notice for California Employees and Job Applicants for further information, this can be found on Prolacta.com on www.prolacta.com . By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to effectively communicate (e.g., talking/ hearing), walk, sit, use hands and fingers to handle, feel and reach things. Employee will frequently lift and/or move up to 10 pounds.

Sedentary to light work; repetitive motions; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal.

EEO Statement

"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.

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