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Quality Control Team Supervisor
3 months ago
Job Title:
QC Team Lead – Regulatory Compliance
Experience:
- At least eight years of experience in pharmaceutical analytical or Quality Control laboratory settings.
- Proven experience with generic pharmaceuticals, particularly in solid dosage form testing.
- Extensive knowledge in chromatography techniques, specifically HPLC and GC, utilizing Empower data acquisition software.
Summary:
This role reports to the Section Head of Quality Control. The incumbent will:
- Oversee activities related to regulatory compliance, including adherence to pharmacopoeia monographs, general chapters, and FDA guidance pertaining to quality control.
- Provide troubleshooting assistance to chemists in the QC Laboratory for new product initiatives, ensuring timely completion of activities and fostering continuous improvement.
- Assist laboratory management in conducting investigations, addressing laboratory incidents, and executing CAPA-related activities to uphold cGMP compliance.
- Facilitate the execution of analytical method transfer activities for new projects.
- Prepare and review technical documentation, such as technical reports, gap assessments, and change controls.
- Offer technical guidance and support to laboratory personnel.
- This position serves as a subject matter expert (SME) without direct reports.
Duties and Responsibilities:
- Contribute to the standardization of laboratory work processes, ensuring compliance with cGMPs and Standard Operating Procedures.
- Verify that analytical procedures align with current compendia and regulatory standards, ensuring suitability for intended purposes.
- Develop and implement procedures, systems, and training initiatives to enhance scientific expertise within the laboratory, ensuring successful project execution to meet industry technical standards and maintain cGMP compliance.
- Collaborate with colleagues across AR&D, RA, QC, QA, MSTG, and external partners to achieve project objectives.
- Support analytical method transfer activities for designated projects.
Work Conditions:
- Work environment is related to manufacturing, production, and warehouse settings.
- Noise levels may be sufficient to cause distraction or potential hearing impairment.
- Exposure to fumes and odors from combustion or chemical reactions may occur.
- Must be capable of physical activities such as bending, lifting, and moving equipment as required.
Qualifications/Education:
- Minimum of a BS in Chemistry or a related field; MS preferred.
- Strong people management and interpersonal skills.
- Ability to organize complex work assignments and oversee staff to ensure timely completion of tasks and projects.
- Comprehensive knowledge of cGMP compliance.
- Excellent understanding of USP, EP, ICH, and FDA guidelines.
- Strong planning, written, and verbal communication skills.
- Exceptional problem-solving abilities.
- A proactive self-starter with a hands-on approach.
- English language proficiency at an Intermediate-B1+ level is required.
The compensation and benefits for this position are subject to the terms and conditions of applicable plans and policies. Employees are eligible for various benefits, including medical, dental, and vision coverage, life insurance, and retirement savings plans. Paid time off benefits are also provided.
EEO Notice:
We are committed to providing equal employment opportunities for all employees and applicants, ensuring no discrimination based on race, religion, gender, age, or any other legally protected status.