Sr. QC Analyst

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 Sr. QC Analyst. This role leads and provides expertise across multiple disciplines within the laboratory and provides method development/validation support. This role is an entry level supervisory developmental role that will direct day-to-day staff activities including assignment of resources.

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...

• Subject Matter Expert in the following laboratory activities:




• Testing of all incoming raw materials, raw milk, in-process, final container and stability samples in an accurate, efficient and timely manner
• Performing environmental monitoring of manufacturing areas and utilities




• Support the development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
• Develop the necessary testing and criteria for the execution of validation studies and projects
• Provide technical solutions to challenges faced by the department that are imaginative, thorough, practicable, and consistent with organization objectives
• Frequent inter-organizational and outside customer contacts. Represent the organization in providing solutions to difficult technical issues associated with specific projects
• Write and review SOPs
• Provide data analysis and trending information to Quality Control team
• Provide subject matter expertise and leadership for the investigation and evaluation of non-conformances related to laboratory testing (OOS, NCs, LIRs, SOPs, CAPAs) and other investigations as necessary.
• Good documentation and investigation skills required
• Understand and follow Quality System Documents relevant to responsibilities and testing (e.g. SOPs)
• Supporting on all analytical activities
• Participate in self-inspections and regulatory inspections
• Understand and follow the Quality System requirements established by Prolacta Bioscience
• Drive department goals/objectives
• Manage and approve employee time sheets, overtime and paid time off
• On-going continuous improvement projects
• Prepare and deliver year-end reviews
• Perform daily team member check-in and respond to issues/requests.
• Perform Good Documentation Practices (GDP) checks on controlled forms.
• Training and cross-training of employees
• Be familiar with area SOPs and ensure standardized work processes and procedures are followed
• Respond to employee issues/requests
• Lead projects
• Direct day-to-day staff activities including assignment of resources - supervise others as assigned
• Able to perform supervisor duties and responsibilities when needed
• Facilitate and/or support Quality Control laboratory 5S; tour/audit ready at all times
• Assist management with team morale, metric reports, employee development, training, etc.
• Complete any other designated tasks, as necessary

What you bring to the role

• BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Chemistry or other applicable related fields; MS/PhD in technical field highly desired
• Minimum of 5 years with BS (3 years with advanced degree) in Pharmaceutical, Biological or Biotech industry; 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 protein chemistry/microbiology highly desired
• In-depth understanding and wide application of technical principles, theories and concepts in the field
• Demonstrated knowledge of Microbiology and Biochemical techniques and other related disciplines.
• Consistent use of best practices and knowledge of internal or external business issues to improve products or services
• Working knowledge of method validation according to ICH (International Conference of Harmonization) Q2(R1)
• Experience working in a laboratory that performs testing within a regulated environment
• Working knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred
• Must be capable of working in an FDA regulated environment
• Good documentation and investigation skills required

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 - Wednesday to Saturday

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.