Quality Control Associate - (Pharma/GMP)

Clinigen • Malvern, PA

11h • Onsite

About The Position

The Quality Control Associate ensures compliance with established quality systems by inspecting incoming clinical supplies, clinical trial labels, and in-process materials. The role performs routine cGMP inspections and disposition and maintenance of clinical trial labels, incoming and in-process clinical trial materials, and finished products. The associate prepares documents for cGMP activities, conducts in-process production inspections, and works with other departments to identify, investigate, and resolve issues. The position requires on-site presence five days per week.

Requirements

• High school diploma or GED.
• Ability to partner with operations and supervisors to identify and correct problems.
• Detail-oriented and self-motivated, with initiative to work independently and as part of a team.
• High regard for confidentiality when handling client, proprietary, and pharmaceutical-related information.
• Excellent oral and written communication skills and active listening ability.
• Excellent time-management skills to prioritize work and meet deadlines.
• Ability to develop effective working relationships with associates at all levels, influence others, and foster a cooperative work environment.
• Highly computer literate, including experience with Microsoft Office software.

Nice To Haves

• Associate degree or two years of equivalent work experience.
• Preferred experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP).

Responsibilities

• Perform routine cGMP inspections, disposition, and maintenance of clinical trial labels, incoming clinical trial materials, in-process clinical trial materials, and finished products.
• Prepare documents for use in cGMP activities.
• Complete in-process inspections during production to ensure products meet quality standards and comply with established quality systems.
• Work with other departments to identify, investigate, and resolve issues using problem-solving skills.
• Communicate operational and personal concerns and opportunities for improvement to department leadership.
• Know, understand, and comply with the company’s standard operating procedures and policies.
• Follow, promote, and enforce relevant SOPs, Job Aids, and company policies and procedures.

Benefits

• A broad range of activities, systems, and programs that provide a competitive benefit offering and support a culture of celebrating success.
• Inclusive company culture with diverse opportunities for engagement and involvement.
• Weekly opportunity to share anonymous feedback with leadership through an employee engagement platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED