Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

The Quality Assurance Specialist II is to ensure compliance with established quality systems in operational Quality Assurance activities.

This position will be Hybrid at our Malvern, PA office.

To be successful in this role you should have:

• Associate’s Degree required; Bachelor’s Degree preferred
• 2-3 years of experience in Quality Assurance / Quality Control related position
• Working knowledge of GMPs, GDPs, ICH guidelines, and EU directives
• Knowledge of pharmaceutical manufacturing/packaging operations or principles and practices involved in clinical trials preferred

Your role at Clinigen:

• Responsible for the review and approval of operational documents, ensuring compliance to cGMP and company SOPs
• Responsible for the final review and disposition of Clinical Trial Material prior to distribution from CCSM
• Ensure the application and compliance of quality systems within operational functions.
• Responsible for the quality oversight of assigned client projects
• Assist the Quality Assurance Manager with QA governance and quality related client meetings for assigned client projects
• Interact with the Quality Control group to resolve review observations
• Assist the QA Manager and the QA Specialist II in all Quality Assurance tasks
• Develop and review quality process related Standard Operating Procedures (SOPs) and controlled forms
• Conduct as needed, company-wide in-service trainings on newly implemented quality related SOPs
• Assist the Quality Systems department to identify and implement quality enhancements and resolve deviations
• Maintain current knowledge of quality assurance-related and regulatory-related government and industry standards as they pertain to the company’s mission statement, values statement and results statement
• Communicate operational and personal concerns, and opportunities for improvement to the department leadership.
• Take responsibility for personal skill development in continuing to learn current trends in pharmaceutical standards and best practices of cGMP
• Knows, understands and complies with the company’s standard operating procedures and policies
• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
• Perform other related job duties or responsibilities as assigned

We’re excited about you if you have:

• Ability to develop and maintain effective working relationships with clients and work associates at all levels of the organization is critical in this position.
• Ability to work well independently or in a team and to be self-motivated in taking initiative along with a strong work ethic is required.
• Excellent oral and written communication skills and active listening ability along with excellent time management skills for working within a fast paced, ever-changing environment is necessary.

While at Clinigen, you’ll enjoy:

The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.

The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.

The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Experience:

• Quality assurance: 3 years (Preferred)
• CGMP: 3 years (Preferred)

Work Location: Hybrid remote in Malvern, PA 19355

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