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.
• Conduct or lead internal audits and external supplier 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.
• Conduct risk assessments.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• 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.
• 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, updating the Quality System database and processing paperwork.
Job Requirements and Qualifications• Bachelor's Degree in Science, Engineering, Business, or technical field with emphasis on statistical skills.
Experience
• Minimum 3-5 years of experience in Quality or related field
• Minimum 1-3 years of Supplier Quality
• Working experience with Supplier qualification and auditing
• Working experience with SCARs and internal audit systems
• Exposure to process and/or software validation methods
Desired Qualifications
• ASQ Certificate: CQE, CQA, CQM, CBA, etc.
• RASQSA or ISO 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.)
Travel
• Ability to travel up to 50% of the time, as needed
Location
• Remote – Occasionally will require onsite support for audits depending on business need. Locations (greater Los Angeles area)
Physical RequirementsDirect Reports
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Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this fication. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so