Manufacturing Compliance Specialist

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 Manufacturing team, which is seeking a passionate individual, to fill the role of our Manufacturing Compliance Specialist. This role is responsible for assisting Manufacturing Leadership team in ensuring all aspects of manufacturing compliance projects are implemented efficiently, successfully, and within the agreed terms of the project while strictly adhering to current Good Manufacturing Practices (cGMP's), Environmental Health & Safety (EHS) guidelines, and other regulations that apply.

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 performing the following...

• Understand manufacturing and quality procedures. Understand manufacturing processes and all applicable FDA and JNDA regulations.
• Author and be responsible for Non-Conformance (NC), Corrective and Preventative Actions (CPA), Change Control Request (CCR), Observation Report (OR), out- of- trend (OOT) investigations and training or other quality system activities.
• Where needed, lead multi-disciplinary teams to investigate, identify root cause and implement appropriate corrective actions.
• Perform Bi annual reviews

• Provide support between Manufacturing, Quality Assurance (QA), Quality Control (QC), Technical Services, EHS, Information Technology (IT) and other departments as needed to execute project activities and tasks.
• Support EHS activities as an EHS Coordinator for the manufacturing department.

• Ensure GMP walk-throughs are completed regularly to ensure compliance.

• Support troubleshooting of process and technical associated problems.
• Initiate and complete document change control to update manufacturing documents which include but are not limited to forms, logs, job-aids, batch records, and Standard Operating Procedures (SOP's).
• Support department goals/objectives including administrative support for data entry (MES data entry) and updating manufacturing metrics and department scorecard reports.

• Provide support to identify, analyze and develop improvements in productivity, quality, client relationships to support company goals.

• Prepare manufacturing metrics for monthly and quarterly meetings.

• Review validation protocols and studies.

What you bring to the role

• B.A./B.S. hard science based degree (engineering, chemistry, biology) and 3 to 4 years of work experience in a GMP manufacturing environment, preferred at least 2 years in a manufacturing or quality leadership role or 10 years of work experience in a GMP manufacturing environment.
• Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 110,117 and ICH is highly desired
• Strong technical writing and communication skills.
• Excellent interpersonal skills to maintain partnerships between manufacturing 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.
• Proficient at computer usage including MS Office (Word, Excel, PowerPoint, and Microsoft project preferred)
• Ability to quickly learn new software including off-the-shelf software or quality system management software, and in-house developed inventory control software.
• Quick to adapt to technology changes including use of tablets or mobile devices.
• Ability to work in a cold environment for a limited period of time.
• Ability to work without supervision
• Working experience in clean room environment
• Ability to produce and present clear, concise and professionally written communications and presentations
• Ability to operate in a complex matrix environment
• Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously
• Strong Critical thinking and decision-making skills
• Strong business ethics
• Scorecard management

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: Split responsibilities between the City of Industry and Duarte locations

Schedule: Monday - Friday

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

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.

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