Quality Compliance Associate Watsonville, CA

Position: Quality Compliance Associate New Watsonville, CA

Reporting to the Quality Assurance Manager, the Quality Compliance Associate is responsible for assisting with all cGMP documentation. This includes the review and editing of controlled documents, change control processing, and cGMP document compliance. Ensure documents and SOP’s are setup correctly to ensure compliance to State, Federal, and International regulating bodies. Duties and responsibilities include assisting site QA cGMP compliance activities.

Other duties and responsibilities as assigned by the Quality Assurance Manager.

ESSENTIAL FUNCTIONS

Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Essential Functions Statement(s)

• Assist the development, interpretation, and enforcement of Quality Systems as per corporate policy and GMP regulations under 21 CFR Part 111 and 21 CFR Part 101. Ensure proper training for QA Personnel on these GMP regulations.
• Provide QA support to manufacturing to ensure that requirements and specifications are met while interfacing with manufacturing partners to ensure we are testing appropriately.
• Provide QA support of Research and Development during new product launches and establishes key checkpoints for new products and processes.
• Review and edit Standard Operating Procedures (SOPs), Work Instructions, and forms to improve Quality Systems documentation that meets quality objectives.
• Assist with internal audits to existing company Quality Systems procedures and ensure all findings are addressed appropriately per cGMP regulations and for continued improvement to the company Quality System.
• Assist in FDA, CDPH, and third-party audits to meet 21 CFR Part 111. Ensure all findings are addressed appropriately to ensure continued certification and compliance to Federal and State regulations.
• Manage supplier qualification including current approve supplier list, associated supplier qualification activities such as establishment, documentation and auditing.
• Other duties as assigned.

POSITION QUALIFICATIONS Competency Statement(s)

• Leadership - Ability to influence others to perform their jobs effectively and to be responsible for making decisions.
• Positive - Ability to view all situations with a positive attitude.
• Innovative - Ability to look beyond the standard solutions.
• Communication - Ability to communicate effectively with others using spoken and written word clearly and concisely.
• Detail Oriented - Ability to pay attention to the minute details of a project or task.
• Negotiation Skills - Ability to reach outcomes that gain the support and acceptance of all parties.
• Strategic Planning - Ability to develop a vision for the future and create a culture in which the long range goals can be achieved.

SKILLS & ABILITIES Specific & Required Responsibilities/

Skills:

• Ensure all quality documents adhere to applicable laws and standards
• Assist with document control process and chance control process
• Perform cGMP internal audits of procedure, processes and documentation to ensure compliance.
• Ensure warehouse and facility compliance to NSF and FDA standards for cGMP practices.
• Keep training documentation for the site.
• Assist in external audits for potential co-manufacturer assessments
• Must have a systematic problem-solving approach
• Able to travel for up to 10% time is required.
• Review and revise SOPs and specification to ensure compliance
• Assist with product review and/or release as needed.
• Must have excellent verbal, written and interpersonal communication skills.

Knowledge, Experience and Skills

• Demonstrates in-depth knowledge of GMPs. Strong working knowledge of cGMPs (US, Canada, and International).
• Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
• Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is a plus.
• Focus on compliance while being able to minimize or reduce testing costs at all times

Computer Skills

• Must be proficient with MS Office/Gsuite and have advanced Excel skills.
• Familiarity with Smartsheet and  project management tools
• Familiarity with SAP is preferred.

Other Requirements

• High school diploma or equivalent, BA/BS Biology, Chemistry or equivalent combination of education preferred.
• Certificates in HACCP, PQCI or auditing a plus.
• 1-2 years of experience in related field within the food or dietary supplement industry.
• Work located at HQ in Watsonville, attendance mandatory on a daily basis.

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