Regulatory Affairs Assistant (Part Time)

POSITION SUMMARY:

• This is a PART TIME position not intended to work more than 29 hours per week. Responsible for assessing and maintaining documentation to ensure ongoing business and manufacturing compliance with external standards and regulations. This position, as directed by the Regulatory Affairs Manager, will assist with reviewing and responding to all matters pertaining to packaging quality and food safety, all applicable plastics regulations, environmental compliance and sustainability, and other topics as needed for all Phoenix Closures, Inc. and JS Plastics, Inc. finished products, raw materials, and facilities.

ESSENTIAL FUNCTIONS:

• Recognize and understand applicable federal, state, local and international regulations, industry standards and customer audit requirements. Assist in identifying potential compliance issues.
• Acquire and maintain the required and up-to-date statements of compliance from the appropriate vendors. Review vendor documents for completeness/missing information.
• Assist in maintaining vendor statements of compliance, including naming of documents following the standard nomenclature, organizing, and electronic filing of documents.
• Review reports, identify issues, and perform actions to correct/resolve issues in the regulatory document libraries in the ERP system.
• Assist in entering new and reviewing existing regulatory/compliance information for raw materials in the ERP system.
• Assist in developing and maintaining a current list of regulatory requirements for incoming raw materials and outgoing finished products.
• Prepare document submissions and responses to customer regulatory requests, such as: FDA Letters, allergen statements, letters of inquiry regarding the absence or presence of various substances, third party audits, surveys/questionnaires, etc.
• Complete other duties as assigned by the Regulatory Affairs Manager to assist with all matters pertaining to regulatory affairs and compliance with internal and external policies and standards.

OTHER RESPONSIBILITIES:

• Maintain testing records for ongoing regulatory or industry standard testing (e.g. CRC protocols).
• Maintain and update Drug Master Files (DMFs) and provide Letters of Authorization upon request.
• Assist Regulatory Affairs Manager as needed. in working with Purchasing Dept. to acquire and maintain documents for supplier approval and monitoring.
• Assist Regulatory Affairs Manager and plant personnel with preparing for select audits as needed (e.g. internal audits, customer audits, and 3rd party external audits) and driving documentation and recordkeeping compliance to those audit requirements.
• Follow all food safety-related policies and procedures.
• Follow all safety rules, policies, procedures and work instructions.
• Participate in Continuous Improvement (CI) efforts for the company.
• Assist with data analysis and occasional technical projects as needed to support department objectives.
• Backup: Regulatory Affairs Manager

EDUCATION AND TRAINING:

• BS degree in Math, Science, or other relevant technical field preferred

SKILLS AND EXPERIENCE:

• At least 1 year of specific experience relating to regulatory affairs, auditing, compliance, and/or analytics, preferably in a food, food packaging, laboratory, manufacturing, or other highly regulated environment.
• Understanding of applicable federal, state, local, and international regulations and enforcement agencies, including but not limited to 21 CFR, U.S. Food Code, CPSC, FD&C Act, EU Directives, EPA, etc.
• Familiarity with various industry standards and auditing schemes (e.g. GFSI / SQF, SEDEX, WCTI standards) relevant to plastics injection molding, manufacturing, and customer markets (e.g. food, beverage, cosmetics, pharmaceuticals, personal care, consumer products, industrial chemicals, et al.).
• Strong computer skills are a must. High proficiency in all Microsoft Office applications and Adobe Acrobat Pro. Familiarity with Pivot Tables and MS Access or other database software preferred. Experience with ERP systems (e.g. DelmiaWorks, SAP, etc.) or computer programming / coding skills a plus.
• Demonstrated excellence in the following skills: detailed analysis of complex technical documents; verbal, written, and technical communication; learning agility; organization and time management; research, critical thinking, and decision-making; exceptional attention to detail; ability to work independently and within a larger team environment.

TRAVEL:

• <5%

EQUIPMENT USED:

• Computer, Calculator, Phone, Printer/Scanner

CONTACTS:

• Various customers, suppliers, Sales, Customer Account Coordinators, Purchasing, Engineering, IS/IT, QA Managers, Senior Management

SUPERVISION / BACKUP:

• Regulatory Affairs Manager