Job Summary

As the Quality Compliance Auditor, you will be responsible for the success of the team and assigned coordinating and managing supplier quality audits. You will also be responsible for leading supplier qualifications, leading internal and external audits, supplier corrective action investigations, monitoring supplier performance, gathering data and reporting on the system performance, and driving improvement activities across the supply change 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.


Primary Duties and Responsibilities

  • Plans, organizes, 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 assure procurements meet or exceed the requirements.

  • Maintain documentation of compliance activities, such as Supplier Corrective Action Reports, Internal and External audit reports and supplier investigation outcomes.

  • Manage and ensure suppliers have Quality Agreements in place and are compliant with internal Prolact procedures and applicable FDA regulation.

  • Conduct or lead internal audits and external audits per the approved annual schedule. Additionally, conduct or lead any unplanned audits per manager’s direction. Responsible for coordination of audit requests and observation responses.

  • Identify compliance issues that require follow-up or investigation.

  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

  • Translates engineering, manufacturing, and quality requirements and compares them to regulations (such as 21 CFR 121,117, 110, 106 and 107)

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

  • Ensure supplier quality promotes improved supplier performance, productivity, and process validation.

  • Reviews and analyzes Supplier Corrective Action Reports in an effort to reduce and eliminate defects.

  • Ensures Supplier Corrective Action Request I Follow-up to ensure consistency in handling corrective actions by suppliers.

  • Develops reports on supplier quality performance compliance

  • Evaluate Information to Determine Compliance with Standards -use relevant information and individual judgment to determine whether events or processes comply with internal procedures, laws, regulations, or standards.

  • Update and Keep up-to-date with state and federal regulations (such as 21 CFR 121, 117, 110, 106 and 107)

  • Organize, Plan, and Prioritize Work - Develop specific goals and plans to prioritize, organize, and accomplish your work.

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

  • Perform Administrative Activities -Perform day-to-day administrative tasks such as maintaining information files and processing paperwork.

  • Continuous evaluates and updates Food Safety and HACCP plans.

 

 Job Requirements and Qualifications

  • Bachelor's Degree in Science, Engineering or technical field with emphasis on statistical skills.

Experience

  • Minimum 5-7 years of experience in Quality Assurance or related field

  • Minimum 3-5 years of Supplier Quality Assurance

  • Working experience with Supplier qualification and auditing

  • Working experience with CAPA and internal audit systems

  • Exposure to process and/or software validation methods

 Desired Qualifications

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

  • 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

  • Experience with Food Safety and HACCP


 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.)

Travel

  • Ability to travel up to 65% of the time, as needed


Location

  •   Multi-Site Locations (City of Industry and Duarte, CA)


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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