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Quality Document Control Specialist

Basic Purpose
Review, file and maintain batch records; file and maintain quality documents. Maintain internal and/or external refences such as FDS regulation, Organic and ISO standards, customer quality manuals, outside testing laboratory test methods and specifications.
Review batch record and enter production formation into various Quality databases daily.
Review quality release information and log entry into various Quality databases daily.
Provide administrative support in broad array of office/data management functions utilizing various data base systems. Perform clerical/secretarial and operational support functions in a professional manner using Microsoft Office.
Tasks are to be completed while maintaining the highest safety, quality, cost and cGMP standards in a high-speed manufacturing environment.
Essential Duties and Responsibilities:
Prepare Quality Department batch record for daily production, including assemble batch record folder, print specification, and assemble all required quality document for each work order.
File and maintain daily batch records -- track work order produced each day, review batch record, enter information into database, and file the batch record.
Maintain annual review quality records - archive batch records, component and material releases, and other quality records, dispose quality record properly, and update quality record database.
Distribute approved procedures, forms, and specifications to affected personnel and maintain distribution history.
Maintain Quality Manual, Procedure Manual, and its history files.
Maintain customer complaint and nonconformance records by using Microsoft Access Database. Lead/Supervisor
Maintain change control database and file records.
Assist the head of Quality Department to ensure quality records meet FDA, Organic, Kosher and ISO 9001-2000 requirements.
Follow all plant guidelines, such as, but not limited to: cGMP's, Quality, Sanitation, Safety
Qualifications
High School Diploma or GED.
Knowledge of cGMP in pharmaceutical or cosmetic products.
Ability to understand and utilize data management systems (Prism, Microsoft Office software, etc.).
Working knowledge of computers, programs and printers including Excel, Word, Power Point, Access, Product Vision and other programs/software as needed.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, fractions, and decimals: compute rates, ratios, and percentages.
Ability to understand/interpret written instructions and procedures.
Strong organizational, problem solving, and analytical skills.
Ability to manage priorities and work flow.
Versatility, flexibility, and a willingness to work within constant changing priorities.
Ability to handle multiple projects and meet deadlines.
Creative, flexible, and innovative team player.
Must be able to speak, read, write, and understand the primary language(s) used in the workplace and organizational levels.

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