Change Control SPecialist

The Change Control Specialist will manage and oversee changes in product development, manufacturing, or distribution processes to ensure they are well-controlled and compliant with industry standards and regulations. This role involves initiating and maintaining the change control process for product design, formulation, manufacturing, or packaging updates. Based in Nashville, TN, the position is open to Canadian citizens eligible for a TN visa.

Visa Requirements:

• Canadian citizens may apply; TN visa required.

Key Responsibilities:

Change Control Process Management:

• Review proposed product and process changes to assess necessity and compliance with industry standards.
• Initiate, document, and oversee the change control process for product design, formulation, manufacturing processes, or packaging.
• Ensure all change requests are reviewed, approved, and implemented according to established protocols.

Compliance and Documentation:

• Maintain compliance with regulatory requirements and industry standards, including FDA, ISO, and GMP.
• Ensure thorough documentation of all change control activities, including rationale, implementation plans, and outcomes.

Cross-Functional Collaboration:

• Collaborate with cross-functional teams, including quality, regulatory, manufacturing, and engineering, to evaluate the impact of changes.
• Communicate effectively with stakeholders to ensure understanding and alignment on change control procedures.

Monitoring and Reporting:

• Monitor the implementation of approved changes to ensure successful execution.
• Generate and present reports summarizing change control activities and compliance status.

Qualifications:

Education:

• Bachelor’s degree in a relevant field such as Computer Science, Life Sciences, Engineering, or a related discipline.

Experience:

• Experience in change control processes within regulated industries such as pharmaceuticals, medical devices, or manufacturing.
• Familiarity with regulatory requirements, including FDA, ISO, and GMP.

Skills and Knowledge:

• Strong understanding of quality management systems and change control principles.
• Excellent organizational and documentation skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in relevant software and tools for documentation and change tracking.

Skills Summary:

• Core Expertise: Change control management, regulatory compliance, quality management systems.
• Industry Knowledge: FDA, ISO, GMP regulations.
• Soft Skills: Organizational skills, cross-functional collaboration, effective communication.
• Tools: Change management and documentation tools.

The pay range that the employer in good faith reasonably expects to pay for this position is $25.43/hour - $39.73/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis. Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.

Salary : $25 - $40