Change Control Specialist

HKA Enterprises; Rocky Mount (NC); On-site; USD 75,000 - 105,000; Full time

Job summary

HKA Enterprises is seeking a documentation specialist to support cGMP compliance and quality systems. The role focuses on implementing documentation systems, coordinating change control, and reviewing procedures to ensure alignment with regulatory guidelines.

Ideal candidates will have strong technical writing abilities, project management skills, and experience with electronic document management systems in a pharmaceutical setting.

Qualifications

• Must meet education/experience combinations listed in the posting.
• Strong knowledge of cGMP, Data Integrity and ALCOA principles.
• Proficiency in document formatting and word processing.

Responsibilities

• Prepare and review essential documentation, including Good Manufacturing Practices.
• Create and manage change controls, change notifications, and change authorizations.
• Implement documentation systems and review procedures and forms.
• Provide input on quality control procedures and documentation for projects.
• Provide technical writing, editing, and design support for policies and training materials.
• Collaborate to develop change management plans and assess impact.

Skills

cGMP

Data Integrity

ALCOA principles

Word processing

Document formatting

Education

High school diploma

Associate’s degree

Bachelor’s degree

Master’s degree

Tools

Microsoft Word

Excel

PowerPoint

Visio

Job description

Position Summary Every day, our commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your expertise will be vital in implementing documentation systems, proposing change control processes, and coordinating the review of procedures and forms. Your dedication and hard work have a significant impact on countless lives.

Role Requirements/ Qualifications

• Applicant must have a High school diploma (or equivalent) with 8+ years of experience or Associate’s degree with 6+ years of experience or Bachelor's with 2+ years of experience or Master's with any years of relevant experience
• Robust comprehension of cGMP, Data Integrity, and ALCOA principles
• Proficiency in word processing and document formatting
• Extensive experience with Microsoft Office applications, including Word, Excel, PowerPoint, and Visio.

3. Nice-to-have/ Preferred Relevant pharmaceutical experience

• Demonstrated expertise in technical writing
• Strong project management skills
• Experience with electronic document management systems
• Knowledge of regulatory requirements and guidelinesAbility to mentor and guide junior colleagues

Key Responsibilities

• Prepare and review essential documentation, including Good Manufacturing Practices.
• Create and manage change controls, change notifications, and change authorizations in compliance with company policies and government regulations.
• Implement and propose documentation systems and change control processes, coordinating the review of procedures and forms.
• Provide input on quality control procedures and documentation, contributing to moderately complex projects and managing time to meet targets.
• Provide technical writing, editing, and design support, creating and updating policies, procedures, specifications, training materials, and other technical documents.
• Collaborate with Functional Area and network customers to develop change management plans.
• Facilitate change management pre-meetings and impact assessments, working closely with project teams to ensure documents are accurate, consistent, and meet internal and external regulatory guidelines.

Physical/Mental Requirements

• Exceptional organizational and communication skills
• Ability to manage multiple tasks and projects simultaneously
• Strong attention to detail and accuracy
• Ability to work independently and as part of a team
• Excellent problem-solving skills
• Strong interpersonal skills