QA Change Control Compliance Specialist

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Location

Chelsea, MA

Summary

Responsible to lead  as the administrator of the Quality System Change Control process and support QA Validation activities. Assist and support with initial compliance and ongoing preparation, conformance to established QA processes and standards for manufacturing. Perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to Change Control and training compliance with internal and external safety, quality, and regulatory standards. 

Full Description

*Essential Duties and Responsibilities include the following. Other duties may be assigned:

  • Develops and documents processes or policies as needed to establish consistent use of the Change Control Process and training requirements.
  • Builds, delivers, and trains end-users; defines processes for reporting, tracking, prioritizing, and evaluating end-user support issues, and basic problem resolution.
  • Provides day-to-day support for change control including administration of documentation with end-users.
  • May participate in enterprise governance committees on common structures, collaborative decisions and problem resolution.
  • Support under the direction of QA GMP Validation group other manufacturing site validation initiatives as needed including facility and engineering projects validation support as required and as the Validation group training coordinator.
  • Support under the direction of QA GMP Validation group Change Control compliance operations including assistance with any risk assessments and coordination with other departments including Regulatory Affairs.
  • Organize meetings and develop metrics for program management for review with site leadership teams.
  • Facilitate internal training on quality assurance requirements, processes, and procedures. May assist with audits, risk assessments, and Validation Protocol and report reviews.
  • Identify risk and evaluate deficiencies while working with internal departments, business units to appropriately remedy them. 

Education and/or Experience:

  • Bachelor Degree in Information Systems, science or related field
  • Minimum of three to five years of working in a cGMP regulated environment
  • Knowledge of Change Control and risk based approaches that meet current regulatory requirements and industry practices
  • Knowledge of FDA and EMA regulations and compliance concepts (e.g. 21 CFR Parts 11, 210, 211, 820).

Supervisory Responsibilities: None

Qualifications:

  • Excellent oral and written communication skills.
  • Presents a solid understanding of quality assurance concepts and practices.
  • Exercises independent judgment to optimize some commonplace compliance procedures.
  • Displays an emerging ability to manage client expectations.
  • Demonstrates emerging skills in influencing others within project teams regarding quality or compliance concerns.
  • Displays an emerging ability to develop innovative ideas for solving problems.

 Computer Skills:

  • Must be proficient in MS Office Suite.

Certificates, Licenses, Registrations:  None required.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Requires physical activity such as standing for long periods of time, walking, bending, and working with hands.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions