Control Specialist

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.

• 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.

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

• 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.

• 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