Quality Specialist (onsite)

Shift Hours:8:00am - 4:30pm CST Monday-Friday

Location: Onsite in Roanoke, TX

Primary Responsibilities:

• Monitors the overall compliance program at the operating level and works closely with the Compliance Manager the Regulatory Compliance Manager
• Assists in reviewing and releasing C2 orders; reviews blanks for completeness after they have been filled
• Assists in counting and verification of inventory; ensures compliance and resolves discrepancies as needed
• Tracks and maintains records as per regulatory requirements
• Control Drug Substance report/ packing slip review
• Scans and/or files courier proof of deliveries for the division
• Assists in formulating general safety policies and procedures in compliance with local, state, and federal OSHA regulations
• Consults with all departments on the design and use of equipment, fire prevention, and safety program
• Inspects facility to detect existing or potential accident and health hazards; recommends corrective measures
• Assists in keeping associates abreast of the dangers of working with hazardous substances
• Participates in the investigation of accidents and work-related injuries
• Assists with the coordination of training programs that will increase safe practices and safety consciousness (DEA and OSHA training for Distribution Center associates)
• Maintains compliance, safety, and security files
• Conducts internal audits to ensure compliance with DEA, DOT, OSHA, and PDMA regulations
• Complies with all appropriate policies, procedures, safety rules, and DEA regulations
• Records daily warehouse temperature readings and reviews forklift inspection sheets
• Assists with maintenance of the Distribution Center's MSDS files
• Brings potential diversion activities and security breaches to the attention of the Compliance Coordinator or the Regulatory Compliance Manager; identifies areas of vulnerability and proposes reconciliation procedures.
• Acts as liaison between customer service and internal compliance requirements.
• Operates as liaison between corporate associates and Federal, State and local regulatory agencies.
• Establishes and promotes the maintenance of a safe, accident free and healthy work environment.
• Maintains all compliance, safety records and security files for the Distribution Center.
• Performs related duties as assigned.

Experience and Educational Requirements:

Requires familiarity with regulatory matters developed either through relevant educational training through completion of a two-year Associate's Degree program, technical vocational training to equivalent combination of experience and education. Relevant experience generally would include regulatory affairs, compliance, or similar vocations. Normally requires a minimum of two (2) or more directly related and progressively responsible experience. Experience in Compliance initiatives, or contract administration of a public or private company is highly desirable.

• Knowledge of legal and regulatory compliance regulations; experience working under DEA and FDA regulations is preferred
• Pharmaceutical industry experience or similar are highly preferred
• Knowledge of Federal, State, and local regulatory agencies preferred
• Proficient computer skills with experience utilizing Microsoft Word, Excel, and PowerPoint
• Ability to follow and interpret government regulatory requirements and changes
• Ability to implement processes resulting in satisfactory audit practices
• Strong judgment and ability to resolve issues effectively
• Ability to work independently, quickly, and efficiently
• Ability to communicate effectively both orally and in writing
• Good mathematical skills
• Strong organizational skills, attention to detail, and interpersonal skills

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. 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. For details, visit https://www.virtualfairhub.com/cencora

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.

The company's continued success depends on the full and effective utilization of qualified individuals. 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. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned