Compliance Analyst

SPECTRUM LABORATORY PRODUCTS, INC.

New Brunswick, NJ

JOB DETAILS
SALARY
$75,000–$90,000 Per Year
SKILLS
Active Pharmaceutical Ingredient (API), Administrative Skills, Analysis Skills, Brand Marketing (Branding), Business Writing, Change Control, Chemistry, Cleanroom, Communication Skills, Computer Skills, Concrete, Consulting, Current Good Manufacturing Practice (cGMP), Customer Relations, Customer Support/Service, Customer/Client Research, Data Analysis, Data Entry, Datasheets, Detail Oriented, Diversity, Documentation, Documentation Review, ERP (Enterprise Resource Planning), Electrochemistry, Environmental Chemistry, Environmental Protection Agency (EPA), Ergonomics, Establish Priorities, FDA (Food and Drug Administration), Federal Laws and Regulations, Field Sales, Government Regulations, ISO 9001, Import/Export Compliance, Inside Sales, Interpersonal Skills, Inventory Management, Laboratory Equipment, Licensing, Maintain Compliance, Mathematics, Medical Equipment, Microsoft Excel, Multitasking, OSHA, Order Processing, Organic Chemistry, PC (Personal Computer) Systems, Physical Demands, Presentation/Verbal Skills, Problem Solving Skills, Product Reviews, Product Shipments, Project/Program Management, Quality Control, Regional Sales, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Requirements, Reporting Skills, Resolve Customer Issues, Sales, Scientific Publications, Spectrum Analyzers, Spreadsheets, Startup, State Laws and Regulations, Supply Chain, Telephone Skills, Testing, Traceability, Trade Shows, United States Department of Justice (DOJ), United States Drug Enforcement Agency (DEA), Warehousing, White Papers, Word Processing, Writing Skills
LOCATION
New Brunswick, NJ
POSTED
7 days ago

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  • Compliance Analyst

Compliance Analyst

Compliance Analyst

Department: Compliance

FLSA Status: Exempt

Reports To: Regulatory Affairs Manager

Prepared By: Regulatory Affairs Manager

Work Location: On-site in New Brunswick, NJ, with hybrid flexibility (2 days WFH) after successful onboarding

Pay Range: $75,000- $90,000/year

SUMMARY

Facilitates screening of regulated chemicals /supplies transactions in compliance to local/state/federal regulations, including documentation screening and review, regulatory data entry in customer file, licensing, data reporting to various regulatory agencies, product review and setup.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Performs analysis of regulated items report and prioritizes review of critical transactions of company products with focus on export/import compliance.
  • Trained in regulations of various agencies - DEA, CA DOJ, FDA, OSHA, EPA, DOT, REACH, State Regulatory Boards, etc.
  • Receive documentation submitted by customers, review for completeness, accuracy, and compliance with appropriate regulatory requirements as per company and department procedures.
  • Prepare and submit DEA/CA DOJ export/import reports as well as state precursor chemicals sales report
  • Review and update customer transactions based on documentation review and regulatory compliance requirements.
  • Interact with Customers or inside and outside Sales Representatives/ Customer Care Representatives to resolve customer documentation issues with their orders.
  • Consult with manager when needed to expedite order clearance process or requests that require further review.
  • Perform data entry of submitted documentation into ERP database, ensuring accuracy and completeness of records.
  • Prepare and submit EHS reports, conduct environmental/regulatory and safety assessments.
  • Assist with data analysis during regulatory audits.
  • Organize the documentation for filing and processing.
  • Review and update appropriate regulatory information on new or updated catalogs and sizes
  • Create regulatory memo, categories and holds in ERP software
  • Prepare and submit API NDCs submissions
  • Prepare product end-use letters as well as TSCA declarations for import clearance process
  • Product review and setup; packaging component compatibility review
  • Other tasks as required or as assigned by department management. This will involve some cross-training in other functions

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Excellent attention to detail
  • Ability to set priorities and manage several projects at once
  • Good verbal, interpersonal and written communication skills
  • Good computer skills (word processing, excel and inventory management/order data entry programs). Ability to become proficient in new software as required. Advanced skills in excel preferred

EDUCATION and/or EXPERIENCE

Bachelor''s degree from four-year college or university. Related work experience in a regulatory environment and/or the chemical, drug, or medical device industries highly desirable. Chemistry knowledge and regulatory experience is highly desirable.

LANGUAGE SKILLS:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, spreadsheets, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and representatives of regulatory agencies.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Ability to use personal computer and telephone. Ability to communicate effectively in written form, verbally, in person and on phone.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Typical routine office/administrative/warehouse environments.

We are an equal opportunity employer and value diversity in our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

How to apply for a position:

Download Employment Application

Download Instrument Experience Questionnaire

(If you are applying for a Chemist or Laboratory position,

please also complete and return our Instrument Experience Questionnaire.)

EMAIL: hr@spectrumchemical.com

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About Spectrum Chemical Mfg. Corp.

Spectrum Chemical Mfg. Corp. leverages more than 50 years of expertise in sourcing, QC testing and repackaging of chemicals provided by other manufacturers to meet the needs of organizations in highly regulated industries. Spectrum Chemical is a certified women's business enterprise (WBE).

Over 200 Spectrum Chemical employees work together across three worldwide locations. We offer more than 45,000 chemicals in laboratory, scale-up and bulk quantities, as well as more than 60,000 supplies, equipment, consumables and PPE. In all, we represent 250 manufacturers and serve 120 industries in 70 countries.

We conduct in-house QC testing by lot to safeguard quality at each of our facilities and provide extensive regulatory and scientific documentation to ensure compliance. We also offer change control, lot traceability and supply chain transparency to eliminate unpredictability. Our products are packaged and stored under cGMP in FDA-registered and inspected facilities.

With our diverse product portfolio and relentless focus on quality, we deliver security of supply to minimize risk and raw material variability, as well as offer highly personalized service and practical consultations to earn your trust and exceed expectations.

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Tools

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About

  • Company
  • Capabilities
  • Quality
  • Core Values
  • Contact
  • Careers
  • Partners
  • Sales Rep Territory Map
  • Trade shows

Resources

  • White Papers and Industry Insights
  • Order Status
  • Online Payments
  • CAS Numbers
  • Certificates of Analysis
  • Safety Data Sheets
  • Scientific Documentation
  • Regulatory Compliance
  • 503B Facilities
  • Spectrum''s W-9

Tools

  • Structure Search
  • Ethyl Alcohol Grade Selector
  • Chemical Hazard Symbols
  • Mesh Conversions
  • Conversion Factors
  • 1200 USP Chemicals
  • Shipping Info
  • Industry Links

Founded in 1971, Spectrum Chemical Mfg. Corp., a division of Spectrum Laboratory Products, Inc., has grown into the chemical industry''s leading customer-focused global supplier of high quality chemicals, laboratory supplies and equipment. Our U.S. facilities are ISO 9001:2015 certified. The California and New Jersey plants are also FDA registered drug establishments and operate under current Good Manufacturing Practices (cGMP).

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SPECTRUM LABORATORY PRODUCTS, INC.