Quality Assurance & Sanitation Manager

Cencora; Shakopee (MN); On-site; USD 85,000 - 115,000; Full time

Job summary

Cencora in Shakopee, MN is seeking a Quality and Regulatory Compliance professional to manage the Quality Management System (QMS) and GDP compliance for the site. The role ensures adherence to applicable state and federal regulations and acts as a liaison with regulatory agencies.

You will drive quality improvement, support inspections, and lead CAPA and change-control activities while promoting a culture of quality across the facility. This is a full-time, on-site position with travel up to 10%.

Qualifications

• Maintains Quality Management System (QMS) and GDP compliance per local and federal rules.
• Conducts regulatory inspections, investigations, and information requests as needed.
• Promotes understanding of USP 1079 (GDP), data integrity and Good Storage, Distribution and Transportation practices.

Responsibilities

• Maintain, execute, and monitor the BU Location’s QMS and GDP compliance.
• Monitor licensure and registrations; liaise with regulatory agencies.
• Lead inspections, investigations, and information requests.
• Conduct Quality, Health & Safety, Security and Regulatory Assessments.
• Drive a culture of Quality and train staff on QMS principles.
• Implement annual Quality Objectives and CAPA processes.
• Perform RCA investigations and risk management activities.
• Use metrics and trends to drive improvements and cost savings.

Skills

Quality management

GDP knowledge

Regulatory compliance

Data integrity

Documentation practices

Training & mentoring

Quality auditing

Risk management

Lean Six Sigma

MS Office

Education

Bachelor's degree in Life Science or related field

Tools

Microsoft Office Suite

Job description

If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Shift Hours:

Monday- Friday 8AM-4:30PM

Location:

This position is located onsite at our facility in Shakopee, MN. There is no option for remote or hybrid work.

This role is in support of Cencora's veterinary and livestock production solutions marketed through our MWI Animal Health business. MWI Animal Health is a leading brand of Cencora, offering animal health services globally.

Under general supervision of the Regional Director, Quality and Regulatory Operations (QRO) with a dotted line to the Regional Director of Quality Assurance, responsible for assuring the business unit (BU) location maintains a robust, effective Quality Management System and security & regulatory compliance effort that aligns with Cencora' s policy and procedures, as well as state and federal regulations.

This position will ensure compliance with the principles of Good Distribution Practices (GDP) and will have the authority and responsibility for ensuring the quality system is in a state of compliance and will facilitate knowledge transfer throughout the operation to help build a Quality and Regulatory Compliance Culture.

• Responsible for the maintenance, execution, and monitoring of the BU Location’s Quality Management System (QMS), Good Distribution Practices (GDP), and compliance with all local state (BOP, DOH, etc.),, as well as all corporate policies and procedures.
• Monitors, verifies, and maintains all BU location local, state, and federal licensure and registrations as required.
• Acts as primary liaison between BU location and all local, state, and federal regulatory agencies. Manages and/or assists with all inspections, investigations, and information requests.
• Conducts required Quality, Health & Safety, Security and Regulatory Assessments.
• Promotes a culture of Quality across the BU location that ensures management commitment and understanding of USP 1079 (GDP), good documentation practices, Data Integrity, and Good Storage, Distribution and Transportation practices.
• Responsible for collaborating with BU location on implementation of annual Quality Objectives (e.g., Right the First Time, Mistake-Proofing, DSCSA compliance) and Key Business Drivers established for DC operations.
• Responsible for supporting and monitoring BU location Quality, Health & Safety, Security and Regulatory training.
• RCA investigation, CAPA identification, and implementation, change control process, risk management, cGMP refresher training.
• Utilize metrics and trend analysis to effectively monitor processes, report on performance, drive improvement and provide cost savings to the BU location.
• Collaborate with Transportation on carrier-related issues where root cause analysis and corrective actions are initiated to improve carrier performance.
• Attend and participate in Regional Quality metric calls/meetings. Represent Quality and Regulatory as a member of the BU location leadership team and Monitors and ensures compliance with corporate policy related to all temperature and security monitoring and alarm systems, access cards, key control, CCTV
• Manages and maintains all DC Power of Attorney documentation for all signers of Schedule 2 order forms;
• Monitors the AB Order Monitoring Program (OMP) at the BU location level to ensure compliance with all corporate, state, and DEA requirements.
• Reviews and verifies that all controlled substance and listed chemical inventories (daily counts, monthly, annual & biennial) are completed and maintained as per corporate policy.
• Ensures BU location investigates all significant inventory variances, thefts and losses.
• Maintains and manages notification and submittal of all correspondence to state and federal agencies regarding losses of Rx, Controlled Substance, and/or Listed Chemical product as per corporate policy.
• Manages and oversees all aspects of the facility’s Health & Safety Program (H&SP).
• Identifies areas of vulnerability and propose reconciliation procedures; Willingness to travel up to 10%.
• Requires broad training in fields such as Life Science or related field, business administration, or similar vocations generally obtained through completion of a four-year bachelor’s degree program or equivalent combination of experience and education; Process-oriented, Continuous Improvement experience such as Lean Six Sigma.
• Good understanding of local, state, and federal laws and regulations. Ability to communicate effectively both orally and in writing
• Effective presentation and training skills
• Ability to follow and interpret government regulatory requirements and changes
• Advanced skills in Microsoft Office Suite

In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. Full time

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.