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How the application process works: Once you click on the ‘Apply now’ button, you will be given a variety of choices for how to submit your profile for consideration for this role. You can apply using a Jobster or LinkedIn profile, or you can import a resume document or build a profile from scratch. You will have the opportunity to check and edit your profile before you submit it to the recruiter.

Product Specification Specialist

Rensselaer, New York, United States

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Salary: Salary not specified | Temporary

Facts about the Role: This is a great long term temporary opportunity that has potential to be very long term or go permanent! This position is responsible for generating and maintaining product specifications as controlled documents in accordance with cGMP requirements and site procedures. This is an opportunity with a growing employer in the Capital Region!

Responsibilities Include:
• Initiates product specifications in accordance with GMPs and site procedures
• Updates, revises and retires existing product specifications
• Initiates and chairs product specification committee meetings consisting of key members of Quality Control, Manufacturing, Regulatory Affairs, Program Management and Quality Assurance
• Collaborates with regulatory sciences personnel to ensure product specifications are consistent with current regulatory filings and commitment

Required Skills:
• Self-motivation - ability to effectively organize and manage work responsibilities independently is a must
• Good time and project management skills with the ability to multitask
• Good interpersonal, written and oral communication skills are required
• Ability to learn and navigate regulatory document management software is a requirement
• Hands-on knowledge of MS word, Excel, and database management systems required
• Prior experience with documentation management and quality systems is a plus, as would prior experience in a regulated field

Education and Experience:
• Requires a BS/BA in the Life Sciences or related field or comparable experience.
• Experience with or knowledge of biopharmaceutical development, testing or manufacturing preferred.
• Previous experience with document/data management systems a plus

How to apply for this position:

Please send your resume to Ashlie Ptak, Resource Manager
Email: Ashlie.Ptak@linium.com
Phone: 518-689-0707

What to expect once you’ve applied:
Once your resume has been received, The Linium team will review your credentials to match your qualifications against all of the open positions, including the one you applied for. If you are qualified for any of the current job openings, a member of the Linium team will contact you.

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