Job Summary:

The Quality Systems Change Control Coordinator is responsible for overseeing and facilitating the change control process to ensure compliance with Standard Operating Procedures (SOPs) and regulatory requirements. This role coordinates change control review board meetings, drives timely completion of change control activities, and collaborates with change control owners and departmental Subject Matter Experts (SMEs) to maintain quality system integrity.

Job Responsibilities

• Facilitates change control review board meetings to ensure effective evaluation and decision-making.
• Reviews change control assessments to confirm compliance with SOPs and regulatory standards.
• Drives change control throughput to meet on-time completion metrics and maintain green status.
• Facilitates meetings with change control owners and departmental SMEs to ensure alignment and progress.
• Ensures notification/approvals for change controls are provided/obtained from customers as per respective Quality Agreements
• Tracks and monitors the status of change control processes, following up with owners to ensure timely actions and completion.
• Communicates updates and closures of change control processes to relevant stakeholders.
• Develops and distributes reports and metrics related to change control activities for trending and performance monitoring.
• Updates SOPs and Work Instructions related to change control processes as required.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
• Performs all work in support of our Values: Innovate, Evolve and Excel.
• Other duties as assigned by the manager.

Education:

• Associate Degree in Science, Business Administration, or related field with 0–2 years of experience, or high school diploma with 3–4 years of experience in cGMP, change control processes, and regulated pharmaceutical/medical device industry practices.

Knowledge, Skills, and Abilities:

• Strong knowledge of personal computers and databases such as MS Office, Word, Excel, and PowerPoint.
• Experience working with cGMP procedures in a pharmaceutical and/or combination device manufacturing facility.
• Experience managing change control processes and writing quality reports.
• Demonstrated ability to work cross-functionally and collaborate with teams.
• Strong communication skills, with the ability to effectively present information and respond to questions from management and/or peers.
• Demonstrated technical writing skills for updating SOPs and Work Instructions.
• Ability to understand and follow operating procedures to perform data entry and develop reports.
• Ability to read, create, and interpret charts and metrics.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Must be able to read, write, and speak English proficiently.

Experience:

• Quality Assurance experience in the pharmaceutical or other regulated industry is required.

Salary : $75,000 - $80,000