Quality Specialist III

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 team, which is seeking a passionate individual, to fill the role of our Quality Specialist III. This 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, safety, and cGXP procedures and systems.
• Understand ICH and PIC/S guidelines for GMP.
• Identify and assess regulatory and quality risks in production and manufacturing with limited supervision, according to applicable regulations and company quality practices. This could include on floor observations and support. Communicate and report product quality concerns in the production lines or anywhere in the facility to appropriate management.
• Lead recall teams and perform recalls/field corrective actions and annual mock recall activities.
• Perform and support donor lookbacks.
• Support annual product quality review initiatives and data gathering.
• Perform non-medical and medical product complaints/adverse events.
• Perform re-review on in-process batch records/manufacturing run sheets and CoAs to support product complaints.
• Perform observations of manufacturing processes in support of product complaint/adverse event investigations.
• Obtain and supply adverse event information from/to a global database and/or call center to support the pharmacovigilance program.
• Prepare Quality Metrics for monthly product complaint meeting.
• Lead risk assessments.
• Lead and support cross-functional teams in the investigation and prevention of discrepancies.
• Review and may approve the following records in the quality system: CPAs, CSRs, NCs, LIRs, and ORs.
• Interface with regulatory agencies, (i.e. FDA) to address questions, present investigations and distribute notifications as required per the CFR.
• As needed, provide technical review for observation reports (OR), nonconformance (NC), CAPA investigations, or laboratory investigations (LIR) and determine effective corrective actions.
• As needed, write observation reports (OR), nonconformance (NC), CAPA, or critical OOS laboratory investigations (LIR).
• Gather data, make interpretations of data generated, and communicate the significance of these results to Quality Management.
• Identify and update procedures that require corrections or updates.
• Identify, lead, and support continuous improvement projects (i.e. kaizens, just do it projects, etc.).
• Attend and lead daily meetings. This may include taking meeting minutes/ notes and communicating information to Quality Management.
• Respond to Hospital requests for information pertaining to Quality Compliance
• Conduct quality tasks in uniPoint and the Manufacturing Enterprise System.
• Generate quarantine records. This may include generating quarantines or assessing material.
• Support with internal/external GMP audits.
• Conduct cross functional training for any applicable departments.
• Provide training to co-workers regarding Quality responsibilities.

What you bring to the role

• B.A./B.S. Degree in Biology, Biochemistry, Chemistry, or other related sciences.
• 5-8 years of experience in a regulated manufacturing environment.
• Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 110, 117 and ICH is highly desired.

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 your first day, to discretionary stock options 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: Hybrid - primary location is Duarte, CA

Schedule: Monday - Friday 8am to 5 pm

Travel: 5%

FLSA: Non-Exempt

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. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. 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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