Quality Assurance Coordinator

Youtheory; Irvine (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

Youtheory is seeking a Compliance Coordinator to support quality assurance and ensure compliance with GMP and relevant regulations. This role involves auditing, document preparation, and investigation of quality deviations. Ideal candidates will hold a relevant technical diploma and possess strong communication and problem-solving skills.

Qualifications

• Minimum two years of practical experience in compliance.
• Moderate knowledge of manufacturing operations and GMP.
• Understanding of Canadian pharmaceutical regulations.

Responsibilities

• Assist in compliance document creation and maintenance.
• Perform internal quality audits to ensure GMP compliance.
• Investigate quality deviations and prepare reports.

Skills

Excellent communication skills

Excellent problem-solving skills

Team oriented

Education

Technical Diploma in Chemistry, Biology, Microbiology, Biochemistry, Pharmacy or an appropriate Life Science

Tools

MS Office

Job description

Description

Nutrawise Health & Beauty, a division of Jamieson Wellness is located in Irvine, California, and is a leading manufacturer of health and wellness supplements, including the award-winning line of youtheory products.

Our youtheory brand is widely distributed online and in club retail locations in the United States and Canada, with a growing global presence.

As a part of Jamieson Wellness Inc., a leading global health and wellness company, and Canada’s #1 VMS brand, our purpose is Inspiring Better Lives Every Day.

Overall Responsibilities

The Compliance Coordinator will assist the Compliance Supervisor in supporting systems, and the creation and maintenance of compliance documents to ensure appropriate compliance with all relevant regulatory requirements. In addition, the Compliance Coordinator will perform internal quality audits for the quality assurance area to ensure the activities as defined by GMP related to natural health and pharmaceutical products are maintained.

Requirements

• Act as the qualified person (as defined under section C.02.006 of Health Canada GMP guidelines, GUl-00001; Section 51 of Health Canada NNPHPD GMP Guidance Document; Section 1.5 of WHO GMP Principles). Responsible for assuring the quality of the finished product is suitable before the product is made available for sale.
• Responsible for the investigation and deviation report writing of quality deviations related to raw materials and packaging components.
• Report and respond to quality/compliance deviations in an expedient manner.
• Responsible for the preparation of Annual Reviews and Trend Reports.
• Responsible for Expiry Assignment Sheets.
• Participate and monitor Change Control Processes.
• Responsible for preparing the deviations related to the quality investigation of the out-of- specification and out-of-trend results relating to raw materials and packaging components.
• Participate and monitor CAPA processes as assigned.
• Assist other departments with compliance-related questions.
• Supports departments by collecting and coordinating internal compliance data for auditors and other areas as required. Assist in the external auditing processes.
• Troubleshoot non-compliance issues as they relate to raw materials, packaging components and sub-contracted vendors and products.
• Responsible for conducting Internal Audits in the quality assurance area.
• Provide assistance to sub-contractors in developing quality-related systems.
• Responsible for annual procurement of batch documentation from non-MRA suppliers for QA review.
• Responsible for the qualification process of raw material vendors, component vendors and subcontractors.
• Participate, prepare and revise (as per required frequency) Quality Agreements with suppliers and subcontractors. Maintain sub-contractor documentation.
• Translate R&D-defined parameters into manufacturing measurable controls to set in specifications and documents.
• Responsible for the creation and maintenance of specifications for raw materials, packaging components, bulks and finished products.
• Responsible for the creation and maintenance of product structures.
• Responsible for the verification and disposition of returns related to raw materials and packaging components.
• Will comply with all Good Manufacturing Practices as established in Jamieson Laboratories policies and documents, and as required by the applicable guidelines.
• Working in compliance with the company's Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities Procedure.
• Will comply with Good Manufacturing Practices in all GMP-sensitive areas of Jamieson Laboratories Ltd. facilities.
• Other duties and projects as assigned

Knowledge, Skills & Abilities Requirements

• Minimum of a Technical Diploma in Chemistry, Biology, Microbiology, Biochemistry, Pharmacy or an appropriate Life Science from an accredited post-secondary institution.
• Minimum two (2) years of practical experience.
• Moderate knowledge of manufacturing operations and GMP
• Moderate knowledge of pharmaceutical, food and natural health product regulations in Canada
• Excellent communication skills
• Excellent problem-solving skills
• Proficient with MS Office software.
• Ability to work with minimum supervision and guidance.
• Team oriented.

Our Values

ACCOUNTABILITY: We do what we say. We take personal ownership for our work and actions and its impact on others and the business.

RESPECT: We do it together authentically and inclusively. We actively listen and engage each other, including diverse perspectives.

EXCELLENCE: We drive to high standard for product, people and planet. We challenge the status quo and bring forward innovative ideas in the continuous pursuit of quality.

AGILITY: We embrace change and act with flexibility. We welcome new ideas and feedback, swiftly incorporating them to improve our performance.