Document Control Specialist

Summary

The Document Control Specialist is responsible for managing company documents and batches, while also ensuring their accuracy, quality, and integrity. The Document Control Specialist ensures adherence to record retention policies, batch record review, and more effectively data retrieval. This position also ensures that Certificates of Analysis (CoA) are prepared correctly and submitted to customers in a timely manner.

Essential Functions

Qualification for this position is predicated not only on satisfactory performance of essential duties as outlined below, but also on compliance with general company policies and procedures and any other duties as assigned. Strict compliance with Company's Attendance Policy is considered an essential duty and responsibility. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Know and follow all of the Company's safety rules, such as safe work practices and standard operating procedures
• Review lot history to ensure that batches have been visually inspected, measured to the necessary 'Acceptance Quality Limit' (AQL) requirement and all relevant paperwork is completed and compliant. Ensure batches are not shipped from QAHOLD or before any non- Conformance reports are complete.
• Serve as a good role model to employees for safe work practices and behavior by conducting yourself professionally, keeping in mind your own safety and the safety of others
• Learn and master all necessary areas of the quality system
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Review production batch records in accordance with Good Manufacturing Practices (GMP) and uphold the standards of the Quality Management System (QMS)
• Monitor processes for adherence to established procedures/regulatory compliance
• Compiles, reviews, and completes production batch records, including raw and test data results, in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
• File and maintain batch records in accordance with GMP and internal procedures
• Creates, adjusts and maintains filing systems for current and archived product master records (PMR), product history records (PHR), and batch records
• Maintain process window and control plan log. Ensure updates are made per the review frequency
• Organize completed inspection records with the production records
• Manages and organizes inbound and outbound product documentation
• Processes document change requests
• Prepare Certificates of Analysis (CoA) in an efficient and timely manner. Assure that all customer specific requirements are satisfied
• Generate C of A upon receipt of product release authorization
• Draft and conduct training as required in relation to Batch Release procedures, documentation, etc
• Ensure continuous feedback to production and QA Lead on issues and problems that may arise
• Retain all results from outside laboratory testing
• Assist in the documentation and resolution of non-conformances and escalate quality concerns as needed
• Write/revise documents, as necessary, and in accordance to good documentation practices
• Assist in the generation and resolution of corrective and preventive action plans (CAPAs) as needed
• Assist in 2ndand 3rd party audits
• Act as a backup to the Document Data Control Coordinator
• Any other duties as assigned

Competencies

• Positive Attitude
• Teamwork and Cooperation
• Flexibility
• Initiative
• Judgement
• Customer Focused
• Organization
• Attention to Detail
• Communication skills
• Ability to multi-task

Supervisory Responsibility

• N/A

Qualifications, Education, Experience, and Training

• High school diploma or equivalent is required
• 2 to 4 years of experience and/or training, or equivalent combination of education and experience
• Demonstrated proficiency in collaborative teamwork
• Good working understanding of Microsoft Word, Excel, PowerPoint, and Outlook
• Ability to prioritize, multitask, and manage time well
• Excellent listening, oral, and written communication skills
• Extremely detail oriented
• Self-directed, ability to work independently, and highly motivated
• Quality Control/Assurance knowledge is preferred
• English B2 Intermediate

Language Skills

• Ability to read, write, comprehend, and communicate the English language in a proficient manner

Computer Skills

• Good understanding and ability to perform tasks using Microsoft Word, Excel, PowerPoint, and Outlook

Math Skills

• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Regularly exposed to moving mechanical parts.

The noise level can be occasionally loud.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to stand, sit, use hands to finger, handle or feel, and reach with hands and arms
• Occasionally required to walk, climb or balance, stoop, kneel, crouch, crawl, and talk and hear
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus
• Occasionally lift and/or move up to 25 lbs.