Quality Systems Associate I

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience's mission! 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 Quality Systems Associate I. Reporting to the Manager, Quality Systems, the Quality Systems Associate I is responsible for workflow compliance in the Quality Management System Software and supporting all departments at Prolacta Bioscience within the regulated environment as applicable to state and federal regulation to meet the department/ business needs and goals.

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...

• Follow quality, safety, and current Good Practice (GxP) procedures and systems.
  
• Review and process the document change controls and other records as needed
  in the Quality Management System.
  
• Enter and maintain master data entry, data security, and quality procedures.
  
• Organize, archive, and oversee quality/ GxP documents from support groups
  within the designated quality-controlled storage areas.
  
• Update and maintain master data entry and book locations owned by Quality
  Systems.
  
• Support identifying and assessing regulatory and quality risks in Quality Systems
  operations according to applicable regulations and company quality practice.
  
• Assist in reviewing Quality Systems operations. Support and document
  continuous improvement initiatives for management review.
  
• Prepare and issue controlled documents such as batch records, lab notebooks,
  and other assigned materials.
  
• Support writing and reviewing procedures, protocols, and reports.
  
• Support collecting data for preparing Quality Metrics report used in Management
  meetings.
  
• Provide general support to departments requiring assistance.
  
• Assist in delivering training on Quality Systems processes.
  
• Coordinate problem-solving meetings and team discussions.
• Participate in internal and external audits and walkthroughs.
  
• Maintain 5S methodology in work areas.
  
• Perform other duties as assigned.

What you bring to the role

• BA/BS degree in Business or Science field and 0-2 years of relevant experience
  in a regulated environment.
• High school diploma or GED with 3-5 years of relevant experience may
  be considered.
• Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR
  106, 107, and 110 is highly desired.
• Excellent interpersonal skills to assist in maintaining a partnership between
  Quality and Operations to ensure the lines of communication are professional
  and congenial.
• Ability to prioritize in a fast-paced environment and keep track of multiple projects
  with different requirements and deadlines
• Detail-oriented and strong documentation, organization skill
• Excellent verbal and written communication skills
• Excellent presentation skills to individuals and groups
• Proficient at computer usage including MS Office (Word, Excel, PowerPoint,
  Access and Visio preferred)
• Ability to quickly learn and adapt to new procedures, and utilize new software
  including quality system management software and in-house developed software

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: This position is located in City of Industry with flexibility to support Duarte, as
needed

Schedule: Monday - Friday

Travel: 10%

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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