Quality Management Lead
Since 1974, TRI-K Industries, Inc. has been a leading manufacturer of specialty ingredients, bringing innovative concepts and products to life for the cosmetics industry. TRI-K strives to keep ahead of the curve with a specialization in cosmetic proteins and multi-functional peptides, natural actives, preservatives, and mild surfactants. TRI-K is a member of the Galaxy Group, with sales offices, manufacturing facilities and partners around the world. At TRI-K, we combine an awareness of consumer trends with innovative technologies to maintain our superior offering in the industry. Our in-house development team is constantly pioneering the discovery of new materials, resulting in enhanced consumer benefits.
We offer a competitive compensation package including:
- 401 (K)
- Paid Time Off
- Life Insurance
- In addition to other programs and plans
Responsible for overseeing and implementing procedures in support of Quality Assurance Program and to promote Manufacturing Excellence. Key member of Proteins Division Quality Unit (PDQU). Manages all ISO, GMP and customer audits. Proactively supports the other members of the Company’s leadership team to assure maximum company performance.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Key member of Proteins Division Quality Unit (PDQU) with authority to approve or release FG & RM, following ISO & GMP Protocols. Provides support, as needed to QC
- Manages all Document Control processes and communicates requirements to all members
- Participates in the review and execution of PD labeling and product modifications, as related to ISO/GMP requirements
- Supports engineering changes through documentation practices, as related to the Quality Management System
- Participates in cross-functional departmental team projects activities/meetings and provides technical assistance as needed
- Responsible for management of ISO/GMP/FDA/USDA compliance documentation, including tracking of KPI’s to support company quality objectives for Audit purposes and communication to members
- Responsible for CAPA processing and documentation from initial complaint receipt through investigation, resolution and communication
- Manages Internal Audit program at PD as well as performing Internal Audits
- Oversees Calibration program throughout the plant, as well as Laboratories
- Conscience keeper with regard to document control (revising/updating in QMS) and updates of SOP – WI Program. Prepares documents, as necessary, in alignment with ISO/GMP Regulatory requirements
- Lead trainer for GMP refresher, CAPA’s and other topics
- Manages recall process in alignment with ISO/GMP
- Quality Assurance oversight of processes, analytical methods and systems
- Manages and oversees customer audits
- Coordinates and manages various external testing to support environmental monitoring programs (ex. Water, cleaning & other validation processes)
- Participates in QA/QC and R & D laboratory activities as needed
- Collaborates with NJ Technical Service department with regard to any overlapping regulatory issues, technical documents or CAPA resolution
- Contributes to safety meetings, initiatives and procedures
- Assists in special projects and presentations, as needed
Required Knowledge, Skills and Abilities:
- Bachelor’s Degree in Chemistry, Microbiology, Chemical or Biomedical Engineering, Life Sciences, or related discipline.
- A minimum five years of directly related experience in Regulatory Affairs in cosmetic ingredients and /or food production environment
- Ability to select, organize, lead, participate, and facilitate a team to produce results.
- Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment.
- Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills.
- Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills.
- Ability to represent Regulatory Affairs to other departments.
- Working knowledge of principle compliance focused ISO Standards and the use of ISO Standards as special controls.
- Proficient computer skills, including MS Office applications (Word/Excel/Power Point/Smart Draw) are required.
Bachelor’s Degree in Chemistry, Microbiology, Chemical or Biomedical Engineering, Life Sciences, or related discipline.
A minimum five years of directly related experience in QC/QA and/or Regulatory Affairs preferably in a cosmetic ingredient or food production environment.
Proficient computer skills, including MS Office applications (Word/Excel/Power Point/Smart Draw) are required.
Certificates and Licenses:
RAC (US or Global) is a plus.
May require minimal travel (post pandemic when travel is permitted)
To apply: https://recruiting.paylocity.com/recruiting/jobs/Details/539008/TRI-K-Industries/Quality-Management-Lead