Job Summary

Join our growing company! This is a mid-level, full time, position with opportunity to be an active team member at Prolacta. We are looking for an individual who is fully competent to serve as a technical resource and contributor in the development and implementation of compliance programs for the organization and the monitoring of business activities for compliance with applicable rules and regulations (i.e. support quality and regulatory compliance for testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling).

Who Are You? 

Do you have a degree in biology or another science-related field? Do you love collaborating to get things done and want to contribute to a larger purpose to save the lives of infants in the NICU? Prolacta’s Quality Control team is seeking a Compliance Specialist to assist our QC team. You will make an impact in the lives of premature infants and their families by choosing to be a part of the Prolacta team.

 

As a Compliance Specialist , you will be an active member of the Quality team working closely with and supporting our multiple systems as they relate to the testing preformed for Prolacta. You will be a trusted partner, proactively anticipating business needs to be able to support our team, leaders, and the clients we support. At Prolacta, your opinion matters. The right person for this role is steadfast, hardworking, and collaborative. If you are energized by working in a dynamic environment and being a true thought partner, then this is a great role for you.

Company 

Company Summary
Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.

Mission Statement

We discover, develop, and deliver life-changing solutions for critically ill babies and other vulnerable patients. We achieve this through innovative human milk research and leadership in quality and safety.

 

Vision Statement 

Giving babies a brighter future by unlocking the biological power of human milk

Benefits and Opportunities

Company Benefits

Prolacta is committed to our employees, which is why we provide outstanding compensation and benefits, including:

 

·         Healthcare: Up to 100% medical, dental, and vision insurance for employees and their families – coverage starting on the first day.

 

·         Compensation: Competitive, performance-based raises and bonuses; discretionary stock options for all employees; 401(k) company match.

 

·         Work/Life Balance: Four weeks PTO accrued within year 1; generous time off program for new parents; flexible work schedules; reserved parking for expectant moms; electric vehicle charging stations on site; company sponsored social events.

 

·         Professional Development: Committed to helping our employees thrive with educational opportunities and leadership programs such as our Women’s Leadership Development Academy and Educational Assistance Program.

 

·         Community Engagement: Company-sponsored community service opportunities for our employees and paid time off to volunteer at your child’s school or at other community organizations

Internal Company Programs

·         Women’s Leadership Development Academy (WLDA)

·         Athari Council

Primary Duties and Responsibilities

·         In-depth understanding and adherence to the Quality System requirements established by Prolacta Bioscience

·         Demonstrates broad understanding of routine laboratory procedures

·         Demonstrates working knowledge of project/process flow within discipline

·         Applies technical expertise and has moderate knowledge of other related business disciplines/policies

·         Identifies areas for continuous improvements and efficiencies

·         Evaluates, selects, and applies standard techniques and procedures

·         Responsible for ensuring QC compliance with all Federal, State, local and company regulations, policies, and procedures related to EHS (Environment, Health and Safety) practices

·         Develop, maintain and report statistical analysis and metrics of QC data

·         Identify emerging trends in laboratory compliance (i.e. FDA, ICH, compendial revisions and laboratory safety), corporate practices, policies, and procedures

·         Identify gaps in corporate practices, policies, and procedures

·         Ensures operating manuals and procedural documents stay current when regulations change

·         Work closely with staff on OOSs (Out of Specification), NCs (Non-Conformance), LIRs (Laboratory Investigation Report), ORs (Observation Report), CAs (Corrective Action) and/or CAPAs (Corrective and Preventative Action) investigations, reports, and root cause analysis for all testing that occurs within the Prolacta and contract laboratory for GMP production, studies, and investigations

·         Utilizes significant knowledge of raw materials and finished goods testing in preparing conclusions and recommendations

·         Work closely with Quality Assurance (QA) to support and ensure inspection readiness in the laboratory for QA Walk-Throughs

·         Work closely with the QA Training Specialist as needed to provide necessary technical support for the training program pertaining to the QC department

·         Provide the support required to generate installation/operation/performance qualifications for QC analytical instrumentation

·         Ensure QC instruments and equipment are calibrated and maintained

·         May operate, maintain, and troubleshoot advanced analysis equipment

·         May make minor adaptations and modifications

·         Support the development and execution of validation studies and research projects

·         Works on simple to moderately complex projects requiring evaluation of materials testing

·         Maintains a safe and clean laboratory

·         Disposes of hazardous/biohazardous wastes according to Prolacta established procedures

·         Performs environmental monitoring (gowning required)

·         Write and/or revise Standard Operating Procedures (SOPs)

·         Provides leadership, guidance, and training to junior colleagues on a regular basis

 

Job Requirements and Qualifications

·         Bachelor’s degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, or related discipline

(OR)

·         At least 4 years of directly applicable experience; hands-on experience in manufacturing, operations, or pilot lab/scale-up operations desired

 

Other Knowledge, Skills and Abilities

·         Business Acumen – Demonstrates thorough knowledge of Prolacta products, operations, strategy, industry trends, and Prolacta SOPs

·         Collaboration

·         Represents the department on specific projects

·         Develops cross-functional partnerships and initiates new and productive internal/external alliances

·         Communication – Interacts with team members, contacts among functional areas, and other departments within the company

·         Computer Skills – Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.)

·         Critical Thinking – Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems

·         Customer Focus

·         Ensures products meet client requirements

·         Assesses customer needs and develops options to meet those needs

·         Assists in presenting options and recommendations to team members

·         Efficient – Performs highly detailed work on multiple, concurrent tasks, while working under strict deadlines

·         Good Judgment – Work may be reviewed upon completion

·         Guidance

·         Seeks ways to share knowledge and skills with others

·         Provides constructive feedback to help others develop

·         Builds consensus, encourages two-way feedback, and acknowledges contributions of others

·         Problem Solving – References and researches established practices, standards and/or policies to provide solutions to a variety of difficult problems

·         Teamwork – Ability to work independently and as part of a team

·         Written/Oral Skills – Regularly required to demonstrate written and oral skills

Work Environment (Location, travel, shift, on-call, etc.)

Travel

·         Up to 5% car travel between locations may be required

Location

·         This position is required to support testing at both the City of Industry and Duarte locations

Schedule

·         M-F 8-5 work schedule

·         Onsite

 

 

Direct Reports

 

·         None

 

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 walk, sit, use hands to finger, handle, or feel and reach, talk or hear. The employee is occasionally required to Taste, smell, stoop, kneel, crouch or crawl. Employee must occasionally lift and/or move up to 10 – 25 pounds (on rare occasions up to 50 pounds). Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

 

Sedentary to light work; walking; fingering; talking; hearing; repetitive motions; stooping; kneeling; reaching; walking; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal; lift/move objects up to 20lbs.

 

Disclaimer

 

The above statements are intended to describe the general nature and level of work being performed by people assigned to thisfication. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel sofied. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

“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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