Specialist Quality Control

Under general direction provide expert guidance in testing and development in molecular biology and microbiology. This role focuses on addressing complex technical issues that span across multiple organizations, sites, or external resources. The specialist will be responsible for troubleshooting assays, ensuring lab compliance with GMP, GLP, and safety standards, and leading audits and investigations to resolve technical challenges.

Key Responsibilities:

• Provide technical guidance to cross-functional teams and resolve complex issues related to assays.
• Ensure effective communication between technical groups, providing updates and resolving any arising issues.
• Develop and implement new programs, processes, and methodologies to enhance testing and development procedures.
• Oversee lab compliance by implementing and refining procedures to meet GMP, GLP, and safety standards.
• Manage and review complex controlled documents that may have multi-organizational or multi-site impact.
• Lead audit teams and represent the department in various cross-functional teams.
• Approve lab investigations and develop technical training materials.
• Interact with regulatory agencies and provide written responses when necessary.
• Supervise staff as required to meet technical needs and ensure quality standards.
• Conduct special projects as directed by the supervisor.

Competencies & Skills:

• Excellent communication, facilitation, and presentation skills.
• Strong technical writing and computer operation skills (word processing, databases, spreadsheets, etc.).
• Proficiency in project management and organizational tasks, including the ability to prioritize and handle multiple responsibilities.
• In-depth knowledge of pharmaceutical testing, validation, manufacturing, and quality assurance processes.
• Extensive knowledge of assay development, validation, and testing within molecular biology and microbiology.
• Strong understanding of GMPs/CFRs and the ability to evaluate compliance issues.
• Proficient in scientific data analysis, problem-solving, and complex data interpretation.
• Ability to lead cross-functional teams and interact effectively with all organizational levels.
• Experience in managing relationships with regulatory agencies and responding to inquiries.

Education/Experience Requirements:

• Doctorate degree in a related field, or
• Master's degree with 3 years of directly related experience, or
• Bachelor’s degree with 5 years of directly related experience, or
• Associate’s degree with 10 years of directly related experience, or
• High school diploma/GED with 12 years of directly related experience.

Preferred Qualifications:

• Knowledge of international regulations and practices related to pharmaceutical/biological product testing.
• Experience in troubleshooting and maintaining lab equipment.

Shift:

• Administrative