QC Stability Specialist I/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 Control team, which is seeking a passionate individual, to fill the role of our QC Stability Specialist I/II position. The QC Stability Group supports testing on incoming raw materials, raw milk, in-process, final product, stability, and facility/utility sampling. In addition to direct testing, the group assists with general quality systems support for the laboratory (i.e., SOPs, CAPA, documentation).

The QC Stability Specialist I is an entry-level role focused on performing routine laboratory testing in support of the Stability Program and daily testing of in-process, finished product, and stability samples. This position will work under close supervision, following established procedures and guidelines, while developing foundational skills in laboratory operations.

The Quality Control Stability Specialist II is an experienced role focused on performing advanced laboratory testing in support of the Stability Program, as well as daily testing of inprocess, finished product, and stability samples. This position operates with a high level of independence, applying established procedures while exercising sound technical judgment across one or more specialized disciplines.

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...

• Follow established procedures and guidelines to perform laboratory testing of stability samples, finished goods, inprocess samples, and incoming raw milk samples, ensuring all work is completed accurately, efficiently, and in a timely manner.
• Demonstrate knowledge of laboratory procedures, project/process flow, and sample management (manual and LIMS), applying policies, practices, and underlying concepts to assigned tasks and projects.
• Perform general microbiological, chemical, biochemical, and ELISA (enzymelinked immunosorbent assay) testing as trained.
• Evaluate the physical characteristics of samples for acceptability and maintain complete, compliant documentation; assist in writing or revising SOPs with increasing independence based on experience level.
• Operate and maintain laboratory equipment, including advanced analytical instruments, and escalate or troubleshoot issues as appropriate.
• Perform environmental monitoring (gowning required) and maintain a safe, clean, and compliant laboratory environment, including proper disposal of hazardous and biohazardous waste.
• Support assigned tasks or moderately complex projects individually or with team members, and may periodically provide leadership, guidance, and training to junior colleagues.

What you bring to the role

Stability Specialist I

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, or related discipline.
• 0-2 years of hands-on laboratory or related experience (internships, co-op, or academic lab work acceptable).
• Familiarity with laboratory practices and willingness to learn stability guidelines under ICH and/or FDA.

Stability Specialist II

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, or related discipline
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  Minimum of 2-4 years hands-on experience in manufacturing, operations, or pilot lab/scale-up operations; experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in nutritional chemistry highly desired. Knowledge with stability guideline under ICH and/or FDA 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 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: Required to support testing at both the City of Industry and Duarte locations

Schedule: 4/10 work schedule - 8am to 7pm, Monday - Thursday

Travel: Up to 5% car travel between locations may be required

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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