Document Control Specialist - Denison Pharmaceuticals

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Who We Are:

Denison Pharmaceuticals is a leading provider of turnkey formulation, manufacturing and packaging solutions for the OTC, Cosmetic, Homeopathic and Pharmaceutical markets. Products include liquids, creams, lotions, gels, and ointments.

Position Summary:

The Document Control Specialist is responsible for managing and maintaining all pharmaceutical CGMP related documents within the organization. This role ensures compliance with regulatory requirements, quality standards, and internal procedures. The Document Control Specialist plays a crucial role in maintaining accurate and up-to-date documentation, supporting efficient processes, and contributing to overall product quality.

Key Responsibilities:

• Responsible for overseeing the document control, record storage/archival, and the change control functions.
• Document Management: Create, Review, and Revise CGMP related documents and records.

• Collaborate with cross-functional teams to create, review, and revise controlled documents, including Standard Operating Procedures (SOPs), batch records, protocols, and forms.
• Document Formatting and Version Control: Ensure consistent formatting, accurate content, and proper version control for all documents in use in the CGMP environment.

• Records Management:
• Document Lifecycle Management: Manage the entire document lifecycle, from creation to archival, assuring compliance with company policies and applicable regulatory requirements (e.g., 21 CFR Subpart J – Records and Reports, etc.).
• Archiving and Retrieval:
• Archival and Retention: Archive inactive documents according to the records retention schedule.
• Document Retrieval: Facilitate timely retrieval of documents for authorized personnel.

• Change Control:
• Change Request Processing: Facilitate the change control process by processing change requests, coordinating approvals, and updating relevant documents.
• Impact Assessment: Assess the impact of proposed changes on existing documents and processes.
• Quality Assurance:
• Audit and Inspection Support: Assist during internal and external audits by providing requested documentation and ensuring compliance.
• Deviations and Corrective and Preventive Actions (CAPA): Participate in deviation and CAPA investigations related to document control issues.
• Training and Communication:
• Training Records: Maintain training records for document control processes and ensure employees are trained in document management procedures.
• Communication: Communicate document-related updates and changes to relevant stakeholders.
• Continuous Improvement:
• Process Optimization: Identify opportunities for process improvement within the document control system.
• Metrics and Reporting: Track key performance indicators related to document control and report on trends.

Skills/Competencies

• Self-motivated, highly collaborative
• Ability to work with ambiguity.
• Self-motivated and a self-starter
• High level of professionalism and confidence to work effectively with employees from all levels of the organization, including senior leaders, functional managers, and the general employee population.
• Proven success in effective communication across all levels of the organization, with the ability to influence key stakeholders.
• Demonstrated strong written and verbal communication skills required.
• Ability to communicate in fast-paced environment with frequent change and challenges requiring daily agility and continual multi-tasking.
• Must be fluent in English.
• Fluency in Spanish, a big plus.

Qualifications

• Bachelor’s degree or relevant certifications, relevant experience (e.g., pharmaceuticals, medical devices, etc.).
• Experience: 1-3 years of hands-on experience with document management in a regulated industry
• Attention to Detail: Strong attention to detail and accuracy in document handling.
• Software Proficiency: Proficient in document management and Microsoft Office Suite.
• Communication Skills: Excellent written and verbal communication skills.

Physical Requirements

• Receive instructions through oral and written communications accurately and quickly.
• Convey answers or instructions to other workers accurately and quickly.
• Must be able to lift and move up to a max. of 20 pounds.
• Employee will be subject to dust, noise, fumes and odors.
• The physical activity of this position includes, but is not limited to:
• Climbing, walking, stooping, kneeling, crouching, reaching, standing, pulling, lifting, grasping, twisting, sitting, feeling, and visual acuity

*Candidate must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

*Please note we are NOT working with recruiters at this time.

*ALL positions are in-office.