Quality Documentation Control Specialist

Quality Assurance Document Control Specialist

The Quality Assurance Document Control Specialist is responsible for day-to-day administration, maintenance, and continuous improvement of the organization's document control within the Quality Management System (QMS) in a regulated pharmaceutical and medical device environment. Ensuring that QMS components are accurate, current, revised, approved, accessible and archived in a compliant manner. The Quality Documentation Control Specialist ensures ProMed's brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Essential Duties & Responsibilities

• Administer the operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, work instructions, forms, specifications, and quality records);
• Maintain document master lists and revision histories to ensure all controlled documents reflect the current approved version;
• Manage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of use;
• Process document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs);
• Assign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirements;
• Ensure document templates are standardized, current, and compliant with applicable regulatory and quality standards;
• Oversee the creation, review, approval and distribution of controlled documents, including SOPs, policies, forms and work instructions with ALCOA principles;
• Maintains the documentation files in compliance with ISO 13485. FDA 21 CFR 820 and 21 CFR Part 11;
• Manage electronic and physical document repositories;
• Support the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completion;
• Coordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely manner as applicable;
• Inputs data to create and revise material and method masters in the ERP system.

Other Responsibilities

• Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager;
• Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities;
• Support the implementation of regulatory changes and quality system improvements as directed;
• Assist in preparing responses to audit observations or regulatory findings that involve document or records management.

Qualification, Education & Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field;
• 0-2 years of experience in a regulated industry (pharma, biotech, or medical device);
• Working knowledge of GMP principles and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820);
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

Preferred:

• Familiarity with eQMS platforms (e.g., MasterControl, Veeva Vault, Agile) even if primary system is paper-based;
• Experience with ISO 13485 quality management principles;
• Knowledge of ALCOA+ data integrity principles;
• Ability to work autonomously, effectively manage time and deliver results on time;
• Attention to detail and commitment to data integrity and accuracy in all quality records;
• Effective written and verbal communication skills; ability to clearly document processes, decisions, and deviations;
• Strong organizational skills with the ability to manage multiple priorities, deadlines, and document workflows simultaneously;
• Collaborative mindset with the ability to work cross-functionally with operations, R&D, and other QA functions;
• Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements;
• Proactive problem-solving skills; escalates issues appropriately and follows through on assigned action items;
• Aptitude for learning and applying regulatory requirements and quality standards.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job:

• Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
• Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
• The noise level in the work environment is usually minor;
• Duties are performed indoors;
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical, Sensory, Cognitive & Neurological Demands

While performing the duties of this job:

• The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
• Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
• The position requires the individual to meet multiple demands from several people and interact with internal and external people;
• Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
• Employee may have duties involving walking on even or uneven surfaces;
• Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
• Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
• It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently;
• Employee must see and hear on a continuous basis as well as speak frequently;
• Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.

ProMed Molded Products, Inc.