Quality Compliance Supervisor

Compliance Supervisor

The Compliance Supervisor is responsible for monitoring and maintaining the plants' Quality systems to ensure compliance to Baxters policies, regulatory, federal, and state laws. Assists in the identification and achievement of facility Quality KPI's through appropriate corrective/preventive actions, and continuous improvement initiatives. Leads all internal and external auditing activities and follow-up. Acts as the Site SQF/GFSI coordinator. Keeps informed on HACCP changes and acts as a resource to ensure regulatory requirements are adhered to.   Provides Quality support during major commercialization projects, assists in new Quality system program implementations. Reports directly to the Quality Manager and serves as a backup to the Quality Manager.  This position will have two direct reports.

 Qualifications

• Preferred 5 years of experience in Quality Assurance, Food Manufacturing, or other technical environment
• Bachelor's Degree is required, preferably in Food Science
• Must be able to work shifts, weekends, and all required overtime (minimal anticipated)
• Strong leadership skills (hard and soft)
• Technical-communication and organizational skills required, along with attention to detail
• Advanced knowledge of quality systems, procedures, and policies
• Knowledge of statistical processes
• Moderate to advanced knowledge of computer systems (excel, visio, word, powerpoint, etc)
• Effective communication skills (oral, written, and verbal)
• Planning and organizational skills
• Successful candidates must possess a positive focus toward solutions with emphasis on preventative proactive measures and team building.
• Demonstrate ability to work with cross-functional groups.
• Preferred, but not required: PCQI, HACCP, IAVA, SQF Practitioner

 Essential Functions & Responsibilities

• Manages all internal and external inspections/regulatory visits. 
• Ensures compliance to customer requirements and contracts.
• Leads audit preparation activities, accompanies inspector, and completes necessary reports and postings. 
• Performs follow up activities to non-conformances found and provides responses, as appropriate. 
• Trains and mentors site personnel on proper inspection procedure practices. 
• Assist in ensuring the facility is always inspection ready.
• Plans, defines, and directs the site auditing program to ensure compliance to all procedures and policies to ensure compliance to regulatory, federal, and local laws. 
  1. This includes identification of facility Quality KPI's, corrective/preventive action and continuous improvement initiatives. 
• Manages execution of site Food Safety Quality Systems Plan (FSQSP) and HACCP programs
• Acts as the Site GFSI coordinator. 
• Ensures all internal procedures, processes are accurate and performing to expectations. Works with internal auditor(s), and document reviewers to ensure compliance and system improvements.
• Provides Quality support for major project commercialization from a regulatory, customer, and Baxters procedural perspective. Periodically audits to ensure appropriate steps, forms, and approvals are completed.
• Supports the updating of Quality refresher training (e.g. GMPs, allergens, foreign object body, pest control, etc.) as needed.
• Manages pest control escalations and follow-ups.
• Ensures plant policies and procedures align to Baxters North America.  Conduit between Plant and Central Quality.
• Ensures Quality policies are understood and communicated to Site employees.
• Supports Food Safety and HACCP meetings.
• Leads HACCP/HAQCP re-analysis and re-assessments.
• Maintains Quality and Food Safety bulletin boards.
• Ensures GMP, glass & brittle plastic, and internal audits are completed in a timely manner and corrective and preventive actions are completed.
• Ensures all equipment is calibrated in accordance with our calibration register.
• Maintains document review and control process (SOPs, WI, Forms)
• Reviews managements of change and ensures quality systems capture scope of change.
• Participates and leads internal audits of the FSQSP and Facility Audits. 
• Provides corrective action (CA) reports in response to audit nonconformances and other findings made by commercial customers and/or regulatory agencies. 
• Assists in consumer complaint investigations and responses. 
• Train, supervise, and provide direction to Quality Specialists.
• Is the back-up/designee in the absence of the QA Manager.
• Other duties, as assigned. 

 Work Environment:

• This position is in a manufacturing plant environment with heavy machinery and equipment. Steel-toed shoes will be required in addition to GMP-complaint clothing.
• Manufacturing plant floor time will be required. 
• Long periods of standing or sitting may be required.
• While performing the duties of this job, you may work near moving mechanical parts and may be exposed to wet, humid, cold, and hot conditions.  
• The noise level in the manufacturing plant is usually moderate and ear plugs are required in certain parts of the plant.

 Physical Demand:

• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 40 pounds.
• Required to stand, walk, sit, and use hands.
• The employee is occasionally required to: reach with hands and arms, climb, stoop, and taste/smell.
• Clarity of vision at approximately 20 inches or less (that is, working with small objects or reading small print), including use of computers.

 Language Skills:

• Ability to express and exchange ideas orally in both an office and manufacturing setting.
• The ability to hear, understand and distinguish speech via in-person speech, telephone, and other remote speech.
• Proficient reading, writing, and comprehension in English.

 Reports To

Quality Manager