Title:  Associate, DEA

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. 

Job Summary:

The DEA Associate will work closely and assist the Manager, DEA Compliance in support of the Sun Pharma Controlled Substance (CS) programs and support Good Manufacturing Compliance programs (GMP) in accordance with all federal regulations, as well as Sun Pharma policies and procedures.  Accountable for DEA reporting and documentation, and conducting periodic audits of respective departments to ensure compliance with DEA regulations

Schedule: Monday - Friday, 8:30am - 5:00pm

Area of Responsibility:

• Submit monthly ARCOS, Year-end reports, and other documentation as needed per DEA requirements

• Assist in daily activities in acquisition and disposition of DEA regulated products as per SOPs of DEA Compliances, Ohm Laboratories Inc.

• Opening CS Vault and Cages as need in Ohm Laboratories Inc.in 2 plants (TR and LA), conduct Inventories and record keepings for DEA inspections.

• Conduct periodic audits of manufacturing and respective departments to ensure compliance with DEA regulations

• Investigate and report non-compliance and take appropriate action(s)

• Interact with local and Federal DEA headquarters to supply and secure import and export permits

• Coordinate with respective departments to compile necessary documentation for submission to DEA of all procurement quota requirements

• Assist external DEA agents and/or Diversion Investigators in onsite inspections

• Develop, evaluate, update and/or implement record keeping procedures for DEA inspections.

• Monitor material accountability during manufacturing, packaging, and testing of drug products

• Coordinate bi-annual, biennial, and year-end inventories of controlled substances and List I chemicals

• Involvement in destruction of schedule of drugs

• Comply with cGMP’s

• Adhere to the Safety and Health Program and associated plans

• Responsible for DEA documentation of procurement and Import quota, Import/Export and ARCOS reporting.

• Operations tracking of all Controlled Substances / List I Chemicals.

• Responsible for conducting the Year End, Biennial and Biannual Physical inventories of Controlled Substances and List I Chemicals, as well as controlled substance destruction activities.

• Tracking all movement of Controlled Substances and List I chemicals (Pseudoephedrine) through the various phases of production in between facilities, third party vendors.

• Reconciliation of all DEA regulated Controlled substances and L1 Pseudoephedrine products at the end of the year and generating Year-end reports for DEA.

Work Conditions:

Corporate Office Environment located in a Manufacturing/Production and Warehouse Facility.

Environmental related to manufacturing/production environments:

• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.

• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.

• Odors: Unpleasant smells.

• Gases: Examples include carbon monoxide and ozone.

• Dust: Airborne particles of any kind, such as textile dust, wood, and silica.

Physical Requirements:

• While performing the duties of this job the employee frequently is required to sit, stand; talk, hear, walk; use hands and fingers to operate a computer, telephone, keyboard and mouse.

• Light lifting up to 50lbs. is required. 

Travel Estimate: 

Up to 5 % travel within 1.5 miles in between 2 plants if needed.

Education and Job Qualification:

• Minimum of a High School Degree required

• Knowledge of 21 CFR 1300- 1301

• Computers skills (SAP, Microsoft Office)

• Organizational and recordkeeping skills

• Auditing and adherence to detail

• Analytical thinking and problem solving skills

• Communication (verbal and written) skills

• A self-starter with a hands-on approach and a can-do attitude. T

• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience:

Minimum four (4) years’ experience in a pharmaceutical manufacturing environment and a minimum of 1 year of DEA related experience, preferred.

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

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