Job Summary

As the Quality Compliance Specialist, you will be responsible for the success of the team and assigned to lead and manage internal quality audits. You will also be responsible for leading supplier qualifications, leading internal audits, supplier corrective action investigations, monitoring supplier performance, gathering data, reporting on system performance, and driving improvement activities across the supply chain and quality management system.  The support to Prolacta Biosciences operations will also include participating in cross functional teams to ensure current Good Manufacturing Practices (cGMPs) and effective risk management.  This is a journey-level position in a career-oriented role.


Primary Duties and Responsibilities

    Plans and reports on all supplier quality-related activities such as raw materials, contracted designed and manufactured items, packaging materials, cGMPs, service providers, and laboratories to ensure procurements meet or exceed the requirements.

     Maintain documentation of compliance activities, such as Supplier Corrective Action Reports (SCAR), internal and external audit reports and supplier investigation outcomes.

     Manage SCARs with vendors; represent the company in discussions in order to negotiate corrective actions for the discrepancies in an effort to reduce and eliminate defects.

     Manage supplier qualification requests in uniPoint.

     Responsible for updating supplier changes (i.e. part number changes, manufacturer changes, material changes, etc.) in uniPoint.

    Conduct or lead internal audits per the approved annual schedule. Additionally, conduct or lead any unplanned audits per manager’s direction.

     Identify compliance issues that require follow-up or investigation.

    Keep current with regulatory rule changes and ensure that they are communicated through corporate policies and procedures.

     Assures that quality or regulatory-imposed requirements are adhered to by supplier and that a quality system is maintained.

     Keep up-to-date with state and federal regulations (such as 21 CFR 117, 110, 106 and 107).

     Plan, execute and prioritize work based upon criticality and urgency.

     Responsible for ensuring timely closure of internal and external audit observations. Ensure audit data is trended and provided to management monthly.

     Responsible for the update and accuracy of the Approved Supplier List for Prolacta.

     Perform activities such as maintaining information files and processing paperwork.

     Prepare Quality Metrics report for Monthly/Quarterly meetings as needed

     Other duties as assigned.

Job Requirements and Qualifications

 

·       B.A./B.S. Degree in Science, Engineering, or technical field with emphasis on statistical skills.

·       3-5 years of experience in a regulated manufacturing environment.

  • Working experience with supplier qualification and auditing.

·       Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 110 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.

·       Executes sound judgement when identifying solutions to a wide range of issues in creative ways.

·       Able to work across multiple departments to perform investigations, provide guidance, and close out corrective actions, etc.

·       Able to perform duties and stay on task without daily guidance or instruction.

·       Must be flexible with hours to accommodate production/business needs.

Desired Qualifications

    ASQ Certificate: CQE, CQA, CQM, CBA, etc.

    RASQSA or ISO 9001:2008 Lead Auditor Certification and Training.

    Operational Excellence/Six Sigma/Lean training or certifications.

    Working experience in cGMP, Food, Nutraceutical, infant formula and/or ISO manufacturing environments.

 

Other Knowledge, Skills and Abilities

 

    Ability to operate in a complex, matrixed environment.

    Must take initiative within role and have a sense of urgency.

    Great attention to detail and must work efficiently.

    Excellent written and oral communication.

    Computer skills (Word, Excel, Access, Adobe Reader, etc.).

    Strong analytical skills, process orientation and teamwork.

    Flexibility of work hours which may include an occasional weekend and/or overtime as needed.

 

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

·       FLSA Status: Exempt

·       Location: Main location Duarte (City of Industry support as needed)

·       Travel: 10%

·       Shift: Day shift

 

Physical Requirements

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Stand

 

 

X

 

Walk

 

 

X

 

Sit

 

 

 

X

Talk or hear

 

 

 

X

Use hands to finger, handle or feel

 

 

 

X

Climb or balance

 

X

 

 

Stoop, Kneel, crouch or crawl

 

X

 

 

Reach with hands and arms

 

 

 

X

Taste or smell

 

X

 

 

 

 

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Up to 10 pounds

 

 

X

 

Up to 25 pounds

 

 

X

 

Up to 50 pounds

 

X

 

 

Up to 100 pounds

X

 

 

 

More than 100 pounds

X

 

 

 

 

Direct Reports

 

N/A

 

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