Regulatory Compliance Specialist

Organization
Catalent Pharma Solutions
Job Location
Winchester, KY
Job Description

The Quality Compliance Specialist is primarily responsible for the day-to-day operations related to controlled substance management and change control activities. Also responsible to ensure site is compliant with Catalent procedures, and support of audits, both external and internal. 

II. Specific Duties, Activities, and Responsibilities: 

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO: 

Change Control Management: 

- Assist with change control system improvements and implementation. 

- Facilitate, evaluate and route change control documents including change risk assessments 

Controlled Substances Management: 

- Maintain current DEA registrations. 

- Maintain controlled substance and listed chemical files (shipping, receiving, Form 222, ARCOS, correspondence, destruction). 

- Complete, reconcile, and report controlled substance and listed chemical inventories. 

- Complete and file ARCOS Quarterly and Year-end reports. 

- Obtain drug quota and raw material to support production in relation to controlled substances. 

- Obtain approval for import/export activities. 

- Responsible for ensuring records (e.g., Master Batch Records, etc) and SOPs pertaining to controlled substances are accurate and complete. 

- Assist warehouse personnel in the shipment and/or receipt of controlled substances. 

- Facilitate outside departments with site-specific controlled substance issues. 

Additional Responsibilities: 

- Assist with maintaining site regulatory documents 

- Support internal and external audits and client relationship management as directed 

- Assist in training other departments related to new/updated procedures. 

- Other related duties as directed by the Quality Compliance Supervisor or Manager. 

- Ensure compliance with cGMPs and applicable Catalent SOPs throughout the facility. 

Primary Location 
United States-KY-Winchester 

Organization 
Advanced Delivery Technologies (ADT) 

Schedule 
Full-time

Requirements: 

Qualifications 

Education: Bachelor of Science required. Five years of pharmaceutical or controlled substance handling experience may be substituted. 

Experience: 3-5 years relevant experience in pharmaceutical industry preferred. 

Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements) 

- 21 CFR 200 to 299, 1300 to End 

- cGMP regulations/guidance pertaining to Pharmaceutical industry. 

- DEA Regulations 

- Effective communication skills. Must have the ability to communicate verbally and in written form with all levels of the organization. 

- Fully competent in the use of common computer software – Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Power Point, and Microsoft Project. 

- Must possess and demonstrate motivational and leadership qualities. 

- Must possess excellent problem solving and analytical skills. 

- Must be well organized and detail and multi-task oriented. 

- Must be able to interact effectively with a variety of individuals and personalities within and between departments and customers. 

IV. Dimensions of Position: 

Scope of Responsibility 

Direct Reports: NA 

Total Staff (includes directs): NA 

V. Physical Requirements and Safety Considerations of the Position: 

Physical Requirements: 

Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Individual will be required to stand for hours for audit tours. 

Work Schedule: 

Shifts of 8 or 10 hours in duration. 

Essential Physical Job Tasks: 

- Completion of administrative duties as indicated by position. 

- Data entry and use of computer user interface tools including mouse, keyboard and any other applicable instruments. 

o Setting up office, desk and workstation for minimal ergonomic risk factors as deemed necessary. 

- Sustaining static postures 

o Sustained sitting at desk or workstation with use of phones, computers and any other office equipment required for specified position. 

o Static stance/standing as required. 

- Lifting and operating in an office environment 

o File/Folder storage with non-repetitive light weight lifting, reaching and forward bending as necessary. 

o Infrequent lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs. 

About Catalent 

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com 

More products. Better treatments. Reliably supplied.™ 

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. 

Notice to Agency and Search Firm Representatives: 

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. 

Job 
Quality/Regulatory

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