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Quality & Regulatory Manager

Employer
AXEL Plastics
Location
Monroe
Salary
Competitive
Closing date
6 Jul 2022

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Employer Sector
Scientific
Contract Type
Permanent
Hours
Full Time
Travel
None
Job Type
Regulation
AXEL is seeking a Quality Manager and Chemical Regulatory Compliance Scientist with domestic and global compliance experience. Reporting to our Technical Director. This position works closely and collaboratively with the other functional areas throughout the laboratory and operations. You will be the leader in the company's Quality & Regulatory compliance team to ensure AXEL's product portfolio of additives and coatings for various commodity and specialty composite materials (i.e. thermoset and thermoplastic resins; urethanes; polymers, etc.) are in alignment with the company s Vision, Values and meet the company s quality and regulatory policies.

Key Responsibilities:

Quality Control
  • Management of quality system activities, to include but may not be limited to: quality management, risk management, audits (both internal and external) quality planning and improvement, quality monitoring and reporting, and quality system training to promote the company and department in achieving its goals.
  • Supervise bench-top testing of Incoming Raw Materials and out-going Finished Products. Experience with using and maintaining various analytical equipment (thermal (DSC/TGA, flashpoints), viscometric, gravimetric, optical (UV-Vis, FTIR, refractive index, color), titration (Karl Fischer, pH, Acid numbers), coating (slip, quality, coalescence) following ASTM methods.
  • The individual will also be adept with Microsoft Office and Excel to design and organize QC data logs, monitor process control, and author finished product certificates of analyses, product specification sheets and reports.
  • Oversee QC of customer complaints and coordinate with customer service and sales teams.
  • Knowledge of SPC statistics and the ability to produce reports.
  • Preparation of PPAP (Production Part Approval Process) reports for customers in the automotive and aerospace industries.


Regulatory
  • Responsibilities also include regulatory-related activities such as management and oversight of regulatory filings and submissions.
  • Regulatory compliance with domestic and global compliance experience to ensure AXEL's product portfolio of additives and coatings for various commodity and specialty composite materials (i.e. thermoset and thermoplastic resins; urethanes; polymers, etc.) are in compliance with appropriate regulatory agencies (TSCA, REACH, DOT, OSHA, NSF, FDA, GHS-SDS compliance).
  • Prepare and file WHMIS applications for Canadian alternative chemical names.
  • OSHA Chemical Hygiene Plan Administration.

Quality Management System
  • Manage and continue developing the company s Quality Management System in accordance with ISO 9001:2015 as the ISO Management Representative.
  • Issue corrective and preventive actions. Maintain log of Risks and Opportunities. Maintain Quality Management System training files. Issue document change notices. Manage internal audits and lead the company s yearly external audit. Lead the organization in continuous improvement process while utilizing the ISO system.
  • Help implement and guide the company to become certified to ISO 14001 & 45001 standards.
  • Production Quality
  • Production Support: Attend meetings supporting plant production via the role of monitoring incoming raw materials, and batch ticket authoring for scale-up and modifications using Chempax VB software (ERP system).
  • Troubleshooting batches, technical aspects of packaging and labelling, replacement raw materials, returns, complaints, and waste stream disposal / EH&S SOPs are also associated activities interfacing with production, the front office and sales.

Desired Qualifications:

Bachelors or Masters in Chemistry, Polymer Science, Chemical Engineering or equivalent relevant degree

5+ years regulatory compliance experience; chemical industry bench work experience highly desired

Demonstrated knowledge of quality and regulations governing the use of chemicals in an industrial setting

Excellent communication skills with experience interfacing with internal (cross-functional teams) and external (vendors; regulatory representatives, etc.) groups at all levels

Small business work experience highly desired

Experience with ISO 9001 or a similar quality management system
  • Strong skills in the Microsoft Office Suite and working knowledge of electronic publishing/file management
  • Enterprise Resource Planning (ERP) systems experience highly desired.
  • Ability to analyze, define, and effectively convey difficult and complex issues in a way that accurately communicates the issues to leadership and internal teams.
Flexible, willing to go the "extra mile"

Calm, with a can-do attitude and the ability to multi-task and meet deadlines

A team-player but able to work on own initiative and with minimum supervision

A problem solver, who seeks solutions

What s in it for you?

Working at AXEL offers a range of fantastic benefits. Our positive company culture and strong values being just two of many reasons to join our great business!

• Excellent career growth and mentorship

• Learning and development opportunities

• Bonus program

• Medical Insurance

• Vacation and Sick Time

• Employee referral reward program

• Competitive compensation package with annual performance and salary reviews

• Most importantly we promote an environment that promotes collaboration where employees have a voice, the space to invent, the chance to excel, and to have fun!

Together, we turn vision into reality by molding our future. Our people are integral to our success and our values reflect the AXEL way.

About AXEL:

AXEL Plastics Research Laboratories (AXEL) is a U.S. based manufacturer of proprietary mold releases and process aid additives for all types of plastics, rubbers, and urethanes. AXEL is a privately held company in its third generation of family ownership and located in Monroe CT. The quality management system has received ISO 9001:2015 certification and the company and its products are fully compliant with REACH and major worldwide regulatory requirements.

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