Siegfried-Athens is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry.
Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization – with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis. Our broad ranging, and often specialized, chemistry capabilities make us the partner of choice for technically intensive and complex projects. Siegfried Athens also has an industry-leading track record in compliance with US FDA cGMPs and other global regulatory bodies.
GENERAL PURPOSE OF JOB
Independently manages day-to-day activities associated with Siegfried - Athens Controlled Substance Compliance (CSC) program. Interprets Federal, International and State controlled substance regulations and develops site processes, practices and procedures to ensure compliance with domestic and international controlled substance laws. Compiles and submits required reports to government agencies. Oversee security of site operations, facilities and shipments to and from Siegfried - Athens.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ensures that Siegfried - Athens is inspection ready for unannounced accountability or scheduled inspections by the Atlanta DEA field office, Georgia Board of Pharmacy or Georgia Drug and Narcotic agency inspections. Serves as the primary point of contact and leads agency inspections.
- Interprets and applies federal and state Controlled substance regulations. Utilizes regulatory intelligence activities to anticipate regulatory changes.
- Ensures un-interrupted supply of controlled materials (imports, exports, shipments). This involves contact with the DEA resolving unusual issues, obtaining special permission and clarification of requirements. Assures an adequate system is in place to track import/export permits. Ensure proper CS documentation is completed for each movement. Develops and monitors reporting DEA requirements. Participates in supply chain escalations that are impacted by DEA processes.
- Initiates or approves deviations and investigations when non-compliance or other discrepancy is identified. Maintains and follows-up on corrective actions, events, and tracks timely closure of CAPAs and investigations.
- Approves change control requests, master data requests, and batch production records. Reviews and signs off on quality events as they relate to Controlled Substance activities.
- Serves as internal subject matter expert by initiating, following up on, negotiating, and resolving matters related to DEA compliance.
- Maintains accurate, well-organized and comprehensive documentation of compliance activities to successfully meet the requirements of the applicable states and DEA.
- Responsible for compiling accountability, usage and inventory information to ensure quota compliance & quota consumption status.
- Compiles and submits DEA & State reports (ARCOS, opiate & NRM estimate (if applicable), import/export, biennial inventory, year-end reporting, research statements, determination letters, NOC requests, distribution history and theft/loss reports).
- Applies for quotas and tracks usage for commercial products, custom synthesis and reference standards.
- Maintains DEA registrations and ensures that required state licenses remain current. Ensure the proper schedules and drug codes are listed on DEA registrations and state licenses.
- Schedules controlled substance disposals with a reverse distributor.
- Manages controlled substance yearly inventories.
- Responsible for management of the Siegfried - Athens’ security program including supply chain security. Oversee the security force to ensure security requirements are met.
ADDITIONAL POSITION 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.
- 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 protective equipment, recognizing, reporting and appropriately responding to hazards in the work areas (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements.
- Participates on investigative teams and site group initiatives (e.g. PHAs, PSC, etc.).
- Is available for other duties as required.
SUPERVISORY RESPONSIBILITIES
- Supervises the contracted security company officers.
- Influences or persuades others to act in a compliant manner every day.
EDUCATION and/or EXPERIENCE
Bachelor's Degree preferred; minimum of 8-10 years related industry experience required; or an equivalent combination of education and experience. Work experience in a DEA regulated, healthcare, pharmaceutical or chemical industry is required.
LANGUAGE SKILLS
- Write reports, procedures and high level correspondence
- Read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Respond to sensitive inquiries or complaints from customers, regulatory agencies, or members of the business community. Provides publications, as required, that conform to prescribed style and format.
- Effectively presents information to top management, public groups, and/or boards of directors.
MATHEMATICAL SKILLS
- Calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
- Apply concepts of basic percentages, fractions, ratios, and proportions and apply them to practical situations.
REASONING ABILITY
- Define problems, collect data, establish facts, and draw valid conclusions.
- Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
OTHER SKILLS ABILITIES OR QUALIFICATIONS
Computer skills:
- Must be highly organized and can prioritize job functions with attention-to-detail and within required timeframes.
- Must have the ability to make independent decisions, surface issues requiring attention and gain assistance if warranted.
- Ability to utilize various word processing and mathematical software applications, customizing them to fit business needs.
- Knowledge of applicable laws and regulations.
- Ability to work with others and influence their opinions and judgment about situations.
- Excellent written and oral presentations skills.
- Strong interpersonal and consultative skills.
- Ability to handle multiple priorities without a loss to productivity while maintaining speed of work and sustained attention.
PHYSICAL DEMANDS
- While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel.
- The employee frequently is required to sit and reach with hands and arms.
- The employee is occasionally required to stand, walk, and talk or hear.
- The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, distance vision, color vision, and peripheral vision.
Purisys considers all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Job Type: Full-time
Pay: $115,000.00 - $140,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Work Location: In person
