About the role

The QA Change Control Specialist II manages the change control lifecycle for pharmaceutical manufacturing processes, ensuring compliance with cGMP and internal SOPs. They coordinate with cross-functional departments to facilitate document reviews, maintain quality metrics, and support regulatory inspections.

What they look for

Change control Quality assurance cGMP SOP development Document control Regulatory compliance FDA regulations Analytical thinking Critical thinking Electronic document management systems Technical writing Proofreading Project coordination Quality metrics Cross-functional collaboration Problem solving

Requirements

Candidates must possess a Bachelor’s degree in a science-related discipline and at least 3 years of experience in Quality Assurance. Strong analytical skills, proficiency in Microsoft Office, and a deep understanding of FDA regulations and cGMP requirements are essential.

Full description

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 level II position requires an individual to perform tasks autonomously with anticipated lead roles for the detailed responsibilities below. There is minimal direct supervision.

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.

Responsible for the review and approval of change controls, as designee, related to new processes, equipment, material, supplier changes in addition to revisions of documents and creation of new documents.

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.

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.

Develop, maintain, and facilitate applicable training around the Change Control process and functions. Support preparation of controlled documents through the change control process including proofreading, tracking, and management through completion.

Collaborate and interact with functional areas within the business (Operations, Quality Control, Research & Development etc.).

Work independently and is able to recognize daily needs with minimal supervision while delivering timely results.

Effectively manage multiple tasks while working under pressure.

Providing support for regulatory inspections including tracking inspection requests, retrieving and copying requested documents, and contacting subject matter experts as needed.

Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures.

Able to independently problem solve, provide investigation support, and support the change management function.

Able to develop and revise Standard Operating Procedures related to the Change Control process.

Establish and maintain quality metrics related to the Change Control process.

Take ownership of continuous improvement initiatives to improve the Change Control process.

Able to provide post-implementation support to all stakeholders and Document Control group.

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 required in science related discipline strongly preferred.

Minimum 3 years experience in Quality Assurance function or related field required.

Advanced computer skills to include Microsoft Word, Excel, Access, Visio or comparable software, PowerPoint, email.

Demonstrated analytical and critical thinking skills.

Knowledge of applicable FDA regulations and established expertise in interpreting and applying to the organization required preferred.

Excellent organizational, interpersonal and communication skills (written and oral) required.

Ability to take feedback constructively and function in a team oriented work environment.

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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