Vacancy expired!
Job Description
Under the direction of the Manager, the Quality Specification Specialist provides support, coordinates and manages specifications for raw materials, bulks (in-house and contract), turnkey finished products for all manufacturing sites and affiliates to meet applicable domestic and international regulations and compliance.
Responsibilities include, but are not limited to:
- Prepare, develop, execute review, and generate specifications and documents to assure compliance to meet internal customer requirements (such as technical services, quality, procurement, regulatory teams, RD, and business teams), manufacturing capability, applicable compendial monographs or market regulations using PLM system.
- As specification change analysts, determine appropriate reviewers/approvers for change requests to ensure specification completeness and integrity including claims to support label requirements.
- Provide technical assistance to internal departments and manufacturing sites on issues related to specifications.
- Ensure generated specifications (manual and electronic) are maintained controlled, updated and communicated to all appropriate levels.
- Participate in cross-functional teams as new products and new raw materials are evaluated.
Qualifications
- Experience/knowledge of FDA regulations and industry standard monograph system as they relate to food and dietary supplements preferred.
- Bachelor’s degree in science required.
- Ability to work independently and meet deadlines on a multitude of concurrent tasks.
- Excellent verbal and written communication skills.
- Computer literacy in a Windows environment (Word, Excel, and Outlook).
- Working knowledge of Current Good Manufacturing Practices (cGMP).
- Strong organizational and analytical abilities.
- Work environment may be exposed to powders, chemicals and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish).
Vacancy expired!