Quality Associate II - Graveyard Shift Tuesday - Friday

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 Associate II. This role 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.

• Review in-process batch records/manufacturing run sheets to support product release.

• Conduct training for cross-functional departments.
• Lead timely investigations for donor lookbacks.
• Conduct SOP and form revisions, including bi-annual reviews.
• Review and approve records in the quality system (i.e. CPAs, CSRs, LIRs, ORs, SCARs).
• Identify and assess regulatory and quality risks in operations according to applicable regulations and company quality practices.
• Lead/write investigations, determine root cause(s) and effective corrective actions, 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).
• Review preventative maintenance forms.
• Support annual product review initiatives.
• Support recalls / field corrective actions.
• Investigate and write product complaints.
• Make limited interpretations of data generated and communicating the significance of these results to Quality Management.
• Review and support the change control process.
• Participate in risk assessments.
• Interface with the Manufacturing Enterprise System and conduct Quality tasks
• Lead / support continuous improvement initiatives (i.e. kaizens, just do it projects, etc.).
• Update procedures and process procedural changes.
• Quarantine incoming raw materials and review for manufacturing release.
  Perform/assist with internal/external GMP audits.
• Prepare Quality Metrics report for Monthly/Quarterly meetings.
• Perform GMP walk-throughs to ensure facility compliance.
• Act as a liaison between Operations and Quality to help trouble-shoot quality related issues.
• Assist with non-conformance investigations and training.

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.
• Working experience in clean room environment.
• Computer skills (i.e. MS Word, Excel, PowerPoint, etc.).
• Effective presentation skills.
• Knowledge of Food Safety plans.
• Working knowledge of continuous improvement a plus.

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: Duarte Office

Schedule: Tuesday - Friday 10pm to 6am

Travel: Occasional travel to the City of Industry office

FLSA: 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