QA Change Control Specialist

Nature and Scope

This position is a member of the Change Control Group and is responsible for implementation of processes and/or changes related to the manufacture of safe, pure, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Change Control Group provides support to other departments as needed and is critical in maintaining production schedules and meeting company goals. The QA Change Control Specialist will participate in all aspects of the Change Control Process. This includes all elements of the change lifecycle such as initiation, assisting all participants, and hand-offs to implementation as per applicable Standard Operating Procedures. The incumbent coordinates and tracks changes to equipment, facilities, processes, and controlled GMP documents in support of the organization's Quality and Compliance needs.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Assessing the adequacy of submitted change controls.
• Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes.
• Assist users with the electronic document management system for the site. Tasks include training new personnel on the use of the system, and coordinating with GxP and service provider to resolve system issues.
• Providing support for regulatory inspections including tracking inspection requests, retrieving and copying requested documents, and contacting subject matter experts as needed.
• Coordinating change control and project meetings, as needed.
• Assessing document drafts for format and content in relation to stated change(s).
• Preparing monthly departmental metrics related to change control and document control processes.
• Preparing product specific change control reviews for Annual Product Review assessments.
• Ensuring the appropriate versions of documents are readily accessible in electronic and/or hard copy form.
• Facilitate applicable training around the Change Control process
• Perform any other tasks/duties as assigned by management.

• We all must embrace the QUALITY culture.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's degree in science related discipline strongly preferred.
• Minimum 1 years of experience preferred in a Quality Assurance function or related areas required.
• Experience with Microsoft Word, Excel, and Access required. Experience with TrackWise preferred.
• Ability to work overtime as needed.

Physical Environment and Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• Ability to work in an office environment including extensive computer activity.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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