Johnson & Johnson companies are equal opportunity employers.
Controlled Substance Compliance (CSC) Specialist II-5912140312
Description
Noramco, Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Controlled Substance Compliance (CSC) Specialist II located in Athens, GA.
Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals. It also produces monomers and polymers for pharmaceutical and medical devices.
The CSC Specialist II will provide technical support by interpreting federal and local Controlled Substance regulations (CSA) as they apply to site processes, practices and procedures. Develop and maintain documentation systems as required by DEA and state regulations, including preparation of all regulatory required reports. Develop and maintain internal accounting and audit systems for DEA regulated products, including conducting and reconciling inventories. Compile inventory information from various departments to complete DEA reports (ARCOS, opiate, import/export, biennial, yearend, etc) as required by DEA regulations. Issue, review, separate and distribute DEA 222 forms on a monthly basis. Complete import/export permit requests. Ensure site compliance with DEA quotas. Monitor lab inventory and disposals to ensure compliance. Participate in local DEA and state of Georgia site inspections. Coordinate destruction activities for all controlled substance and list chemical materials. Initiate Trackwise investigations when non-compliance is identified. Act as site SME for the DEA Trackwise workflow. Compile data to support department metrics. Participate in the development and delivery of training for site control procedures required for DEA compliance. Serve as primary contact for site controlled substances transfer activity. Perform site GEMBA tours to verify DEA and security compliance. Perform internal audits of site controlled substance processes. Conduct security inspections of carriers, customers and suppliers for compliance of DEA security regulations. Respond to sensitive inquiries or complaints from customers, regulatory agencies, or members of the business community. Ensure required out-of-state state licensing remains current. Participate in RTE and S&OP meetings. Assists other departments in understanding and complying with DEA reporting needs.
Successfully completes regulatory and job training requirements. Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures. Makes a positive contribution as demonstrated by: making suggestions for improvement; providing overtime as needed; learning new skills, procedures and processes. Is available for other duties as required. Remains current in skills and industry trends.
Qualifications
A minimum of an Associate's degree (A. A.) or equivalent from two-year college or technical school and at least two years related experience required. BA/BS Degree preferred. Work experience in the pharmaceutical or chemical industry preferred. Experience in working in a DEA regulated environment preferred. Must possess the ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies and the general public. SAP experience is preferred.
Must be able to demonstrate effective interpersonal and consultative skills in a team environment. Advanced knowledge of MS Office applications is required. Must possess an organized approach to working in a multi-task position with excellent attention to detail and deadlines with a sense of urgency. Must possess analytical and project management skills. Must have demonstrated ability to work with all levels of people using an objective viewpoint and a focus on customer service. Strong problem/conflict resolution skills and excellent verbal and written communication skills are required. Demonstrated ability to prioritize work with general guidance from supervisor is required. Must be able to demonstrate initiative as problems and/or opportunities arise; is action oriented; able to anticipate what activities need to be done, not only as directed.
This position is located in Athens, GA and may require up to 15% travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI NA
Primary Location:North America-United States-Georgia-Athens
Organization: Noramco, Inc. (6109)
Job Function: Regulatory Compliance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Controlled Substance Compliance (CSC) Specialist II-5912140312
Description
Noramco, Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Controlled Substance Compliance (CSC) Specialist II located in Athens, GA.
Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals. It also produces monomers and polymers for pharmaceutical and medical devices.
The CSC Specialist II will provide technical support by interpreting federal and local Controlled Substance regulations (CSA) as they apply to site processes, practices and procedures. Develop and maintain documentation systems as required by DEA and state regulations, including preparation of all regulatory required reports. Develop and maintain internal accounting and audit systems for DEA regulated products, including conducting and reconciling inventories. Compile inventory information from various departments to complete DEA reports (ARCOS, opiate, import/export, biennial, yearend, etc) as required by DEA regulations. Issue, review, separate and distribute DEA 222 forms on a monthly basis. Complete import/export permit requests. Ensure site compliance with DEA quotas. Monitor lab inventory and disposals to ensure compliance. Participate in local DEA and state of Georgia site inspections. Coordinate destruction activities for all controlled substance and list chemical materials. Initiate Trackwise investigations when non-compliance is identified. Act as site SME for the DEA Trackwise workflow. Compile data to support department metrics. Participate in the development and delivery of training for site control procedures required for DEA compliance. Serve as primary contact for site controlled substances transfer activity. Perform site GEMBA tours to verify DEA and security compliance. Perform internal audits of site controlled substance processes. Conduct security inspections of carriers, customers and suppliers for compliance of DEA security regulations. Respond to sensitive inquiries or complaints from customers, regulatory agencies, or members of the business community. Ensure required out-of-state state licensing remains current. Participate in RTE and S&OP meetings. Assists other departments in understanding and complying with DEA reporting needs.
Successfully completes regulatory and job training requirements. Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures. Makes a positive contribution as demonstrated by: making suggestions for improvement; providing overtime as needed; learning new skills, procedures and processes. Is available for other duties as required. Remains current in skills and industry trends.
Qualifications
A minimum of an Associate's degree (A. A.) or equivalent from two-year college or technical school and at least two years related experience required. BA/BS Degree preferred. Work experience in the pharmaceutical or chemical industry preferred. Experience in working in a DEA regulated environment preferred. Must possess the ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies and the general public. SAP experience is preferred.
Must be able to demonstrate effective interpersonal and consultative skills in a team environment. Advanced knowledge of MS Office applications is required. Must possess an organized approach to working in a multi-task position with excellent attention to detail and deadlines with a sense of urgency. Must possess analytical and project management skills. Must have demonstrated ability to work with all levels of people using an objective viewpoint and a focus on customer service. Strong problem/conflict resolution skills and excellent verbal and written communication skills are required. Demonstrated ability to prioritize work with general guidance from supervisor is required. Must be able to demonstrate initiative as problems and/or opportunities arise; is action oriented; able to anticipate what activities need to be done, not only as directed.
This position is located in Athens, GA and may require up to 15% travel.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI NA
Primary Location:North America-United States-Georgia-Athens
Organization: Noramco, Inc. (6109)
Job Function: Regulatory Compliance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement