Document Specialist

GENERAL DESCRIPTION

The Documentation Specialist is responsible for preparation and management of product/process documentation, including, but not limited to Raw Material & Component specifications, Finished product specifications, and general workflow coordination. Works closely with R&D, Quality, Manufacturing, Procurement, Quality and other functional areas.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential job functions. Essential job functions and duties include, but are not limited, to:

• Prepares, revises, reviews, and coordinates workflow of Raw Material, Component, Finished product specifications per approved SOPs and pertaining documents.
• Prepares customized templates for Certificate of Analysis (CofA) for finished products following Customer’s requirements and BF guidelines and procedures. Tracks CofA requirement changes by customer
• Works with Purchasing Department & R&D personnel on obtaining various vendor and customer technical or regulatory documentation and & certifications
• Coordinates and tracks documentation routing for approval, and ensures timely documentation approval. Maintains approved documentation in a required chronological order and filed appropriately, and appropriate level of separation for obsolete and current approved specification.
• Communicated current status of documentation set up to Quality, Customer service and other personnel
• Issues Standard Operation Procedures for R&D functional processes
• Follows established department SOP's, cGMP regulations, and batch record instructions.
• Complies with all Company policies and procedures, including safety rules and regulations.
• Maintains a safe work environment and operates in a safe manner.
• Perform other job duties related to the job, as assigned by management.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:

• Strong Excel Proficiency
• Proficient skills in reading, writing, and speaking in English; bilingual skills a plus.
• Excellent written and oral communications skills & techniques.
• Effective planning & organizing skills; ability to handle multiple task/duties.
• Understanding of Dietary Supplement dosage form manufacturing processes & procedures is a strong plus
• Proficient with Microsoft Office Products.
• Effective problem-solving skills.
• Knowledge of general office skills and administrative procedures, including, but not limited to: typing, filing, copying, faxing, editing, and development of memos, letters, reports, and correspondence.
• Ability to work independently and in a team environment
• Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position.
• Ability to comply with Company policies, procedures, work rules, and protocols.
• Ability to adapt effectively to workplace changes and new job duties/responsibilities.
• Ability to represent the Company in a positive and professional manner at all times.

Monday through Friday
8:30 am to 5:00 pm

E-Verify and Background Required