Job Description
The Document Control and Manufacturing Quality Assurance (MQA) Manager is responsible for overseeing the company’s document control system, ensuring compliance with Good Documentation Practices, and providing direct quality oversight of manufacturing records and forms. This role administers and maintains the electronic document control system, manages document change control for policies, procedures, and forms, and ensures all manufacturing documentation meets ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate). The manager also performs final QA review and approval of manufacturing records, ensuring compliance with OTC pharmaceutical and cosmetic GMP requirements.
Quality Specific Responsibility
Ensure all operations are conducted in compliance with applicable regulatory requirements, Good Manufacturing Practices (GMP), and company quality standards. All Hydrox Laboratories Supervisors and Managers are responsible for understanding, implementing, updating and maintaining adherence to Standard Operating Procedures (SOPs), ensuring employees follow approved procedures, and promptly addressing or reporting any deviations from established quality or regulatory requirements.
Every leader is accountable for maintaining a culture of quality and ensuring Hydrox standards consistently meet or exceed both internal expectations and customer requirements.
Duties & Responsibilities
· Administer and maintain the electronic document control system, ensuring accuracy, security, and regulatory compliance of all records in the system.
· Lead document change control processes for policies, SOPs, work instructions, batch records, and controlled forms.
· Oversee manufacturing documentation practices to ensure adherence to ALCOA and GDP principles.
· Provide QA oversight of all manufacturing forms, logs, and batch records, including final review and approval.
· Ensure compliance with OTC drug GMPs (21 CFR 210/211), cosmetic GMPs (ISO 22716), and internal quality standards.
· Train employees on Good Documentation Practices, document control procedures, and proper recordkeeping.
· Support internal and external audits by providing documentation and demonstrating system compliance.
· Collaborate with Manufacturing, Quality, and Regulatory teams to ensure documentation accuracy and readiness.
· Manage the lifecycle of controlled documents, including creation, revision, approval, issuance, and archival.
· Maintain the electronic document control system, including user access, workflows, and periodic reviews.
· Review and approve document change requests, ensuring proper justification and impact assessment.
· Oversee the creation and maintenance of manufacturing forms, ensuring they meet regulatory and operational needs.
· Conduct routine floor checks to ensure proper documentation practices and identify gaps or training needs.
· Perform final QA review of batch records, logbooks, and manufacturing documentation for completeness and compliance.
· Ensure timely closure of documentation errors, corrections, and deviations related to recordkeeping.
· Maintain document control metrics and provide periodic reports to leadership.
· Support audit preparation and provide documentation during internal, external, regulatory or customer audits.
· Update and maintain SOPs related to document control, GDP, and manufacturing documentation processes.
Knowledge, Skills and Abilities
· Strong understanding of OTC drug regulations, including 21 CFR 210/211, OTC monographs, and documentation requirements.
· Knowledge of cosmetic GMPs, including ISO 22716 and labeling requirements under 21 CFR 701/740.
· Deep familiarity with Good Documentation Practices and ALCOA principles.
· Knowledge of document control systems, workflows, and regulatory expectations for controlled documents.
· Understanding of manufacturing processes for OTC topicals, skincare, haircare, and cosmetic products.
· Knowledge of batch record structure, manufacturing logs, and QA review requirements.
· Strong attention to detail and commitment to documentation accuracy.
· Excellent organizational skills with the ability to manage multiple documents and workflows simultaneously.
· Strong communication and training skills for educating staff on GDP and documentation requirements.
· Proficiency with electronic document management systems (EDMS) and quality management software.
· Ability to interpret and apply regulatory requirements to documentation and manufacturing processes.
· Strong analytical and problem‑solving skills for identifying documentation gaps and implementing improvements.
· Ability to collaborate effectively with cross‑functional teams in a fast‑paced manufacturing environment.
· Familiarity with FDA inspections and customer audits.
Qualifications
· Associates or higher degree education in Life Sciences, Quality Management, Chemistry, Biology, or a related field. Experience will be considered in lieu of degree.
· 3+ years of experience in document control, manufacturing QA, or GDP oversight within OTC or cosmetic manufacturing.
· Experience administering electronic document control systems.
· Experience with ALCOA, GDP, and cGMP documentation requirements.
· Experience performing QA review and approval of manufacturing records.
· Certifications such as ASQ CQA, Document Control Specialist, or GDP/GMP training are advantageous.
Working Condition
This position primarily works in an office environment with frequent interaction in manufacturing, warehouse, and laboratory areas of an FDA-regulated OTC pharmaceutical and cosmetic manufacturing facility. Regular use of computers, document management software, and standard office equipment is required to administer and maintain the electronic document control system and review manufacturing documentation.
The position requires frequent sitting, standing, walking, and the ability to move throughout the facility to support document control activities, review manufacturing records, conduct document audits, and collaborate with cross-functional teams. Occasional lifting of up to 25 pounds may be required. Employees must be able to visually inspect documents and electronic records and perform prolonged computer work.
While on the manufacturing floor, the employee is required to wear appropriate personal protective equipment (PPE) and comply with all safety, quality, and Good Manufacturing Practice (GMP) requirements. Exposure to manufacturing noise, chemical odors, varying temperatures, and production equipment may occur. The role may require occasional extended hours to support document revisions, quality investigations, audits, regulatory inspections, or business needs.
This job description lists the major duties and requirements of the job and is not all-inclusive. Incumbent may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.
Pay: $95,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
