Job Description

Under the direction of the Senior Manager, Quality Compliance, the Supervisor of Material Specifications is responsible for the development and governance of all product specifications including raw material, bulk / finished product, and packaging material specifications.



This position is responsible for overseeing the development of robust specifications that are in alignment with all applicable regulations and pharmacopoeias, ensuring that test methods are aligned with internationally recognized standards as defined by USP, EP, AOAC, FDA-BAM, etc.



In addition, this position has oversight for the compliance review of label artwork from a Quality perspective, including the blister standard/mock- up approval process to ensure quality standards are maintained.



The Supervisor of Material Specifications must demonstrate scientific technical knowledge, strong leadership, possess initiative, and maintain a strong commitment to quality and compliance.

Key Responsibilities for this position:

Responsible for the creation and maintenance of raw material, bulk, finished product and packaging material specifications Determines certificate of analysis requirements needed to ensure materials meet physical, chemical, and contaminant requirements Works in close collaboration with key stakeholders to conduct material assessments as part of the specification development process. Evaluates proposed changes in CCRs and assesses potential impact to specifications Supports regulatory filings in relation to specification creation Ensures specifications are current with all applicable regulations and pharmacopoeias Oversee personnel in completing tasks and projects to schedule Support internal, external audits, as well as Regulatory audits, as assigned Update SOPs as needed.

Qualifications & Experience Required:

Minimum of 3 years of experience working in Quality Assurance or Quality Control functions. Prior supervisory experience in a GMP regulated environment is preferred Experience with the development and governance of pharmaceutical raw material, bulk / finished product, and packaging material specifications in accordance with pharmaceutical regulatory requirements is preferred Understanding of pharmaceutical manufacturing environments, material usage, and QC testing requirements

Education, Certification, Licenses & Registrations:

Bachelor of Science in Chemistry, Biochemistry or another related field

Skills:

Superior communication skills (verbal and written) are required. Ability to plan, organize, prioritize, and manage multiple projects simultaneously in a complex, fast paced environment to meet deadlines. Possesses critical thinking skills; able to exercise independent judgment and propose innovative solutions to resolve unique challenges with minimal oversight. Must be capable of collaborating in a team environment. Should be able to influence decisions through effective communication, while maintaining flexibility in response to changes in priorities.

Physical Demands:

Prolonged periods of sitting at a desk and working on a computer Frequent use of hands and fingers for typing, handling documents and operating office equipment Occasional standing, walking, bending or reaching Visual acuity required for reading printed materials and viewing a computer screen Ability to communicate clearly in person, over the phone and in writing



At IVC Vita Health, we are dedicated to building a workplace that is diverse, equitable, and inclusive. We believe our greatest strength comes from embracing different perspectives, backgrounds, and experiences. Our goal is to create an environment where every individual feels respected, valued, and empowered to thrive.


We welcome applicants from all walks of life, including--but not limited to--women, Indigenous peoples, racialized individuals, persons with disabilities, and members of the LGBTQ+ community.


We are committed to fair and inclusive hiring practices and strive to foster a culture where all employees have the opportunity to reach their full potential. If you require accommodation during the recruitment process, please let us know, and we will do our best to support your needs.


Please note: This job description is intended to outline the general nature and key responsibilities of the role. It is not a comprehensive list of duties. Management reserves the right to assign or reassign responsibilities as needed to meet operational requirements.