Quality Assurance - Document Control Clerk (Pharma)

Our client located near Hauppauge is in immediate need of a candidate to work new product development as a Quality Assurance Clerk. Our client prefers a candidate with batch record review skills (pharmaceutical).

Hours: Monday - Friday 7:30 a.m. - 4:00 p.m.

Description:

The Quality Assurance – Document Control Clerk is responsible for ensuring that the company complies with Standard Operating Procedures as well as federal regulations and industry guidelines for each master batch record as well as associated production and quality paperwork.

Principal duties and responsibilities for this position include:

• Create and update Product Specifications, including both Raw Material and Finished Product Specifications in compliance with current labeling regulations and testing requirements
• Compile allergen information for all raw materials and finished products and update product folders with new allergen information requirements
• Maintain and ensure that the Raw Materials List with Critical Allergens is current and up to date
• Assist in managing the overall coordination and issuance of batch records, including but not limited to the creation, approval, and control of Master Batch Records within the company
• General office duties or filing as required

Qualifications:

• Computer proficiency in word, access, excel and outlook
• Strong verbal and written communication skills, as well as strong organizational skills and ability to prioritize and multi-task
• Excellent analytical, problem-solving and decision-making skills
• Must have good vision, aided by glasses if necessary, and be able to remain seated for prolonged period
• Experience in pharmaceutical environment, science or regulatory background preferred
• Ability to write reports, business correspondence, and procedures
• Basic understanding and utilization of scientific and technical language and symbols