Quality Assurance Laboratory Lead
2 months ago
Position Overview:
As a key member of the management team, the Quality Control Supervisor will oversee laboratory operations, ensuring adherence to quality standards and regulatory compliance. This role involves providing leadership and support to laboratory personnel while managing the workflow of various testing processes.
Key Responsibilities:
- Direct the daily operations of quality control testing, optimizing staff and equipment use.
- Ensure the proper maintenance and qualification of laboratory instruments, assisting with troubleshooting as needed.
- Facilitate training and provide guidance to laboratory staff to enhance their skills and performance.
- Review laboratory test results to ensure timely reporting and data release.
- Manage offsite sample testing and maintain oversight of testing statuses.
- Uphold cGMP standards and ensure laboratory systems are compliant with regulatory requirements.
- Prepare and evaluate documentation related to laboratory activities and production processes.
- Maintain accurate laboratory records and documentation systems.
- Provide on-call support for laboratory operations, covering various testing types.
- Collaborate with cross-functional teams to meet project timelines and deliverables.
- Verify timekeeping and billing processes to ensure accuracy.
- Conduct quality control releases for raw materials and finished products.
- Identify and address discrepancies, managing investigations and corrective actions as necessary.
Qualifications and Skills:
- Knowledge of cGMP compliance and safety regulations.
- Experience with analytical instruments such as HPLC, GC, and UV-VIS.
- Proficient in computer applications including word processing and data management.
- Strong foundation in chemistry principles.
Educational Requirements:
- Bachelor's Degree in Chemistry, Pharmacy, or a related field is required; an advanced degree is preferred.
- A minimum of 5 years of experience in a laboratory setting within the pharmaceutical industry, with a focus on manufacturing support.
- Experience managing laboratory operations, particularly in a 24/7 environment, is advantageous.
All qualifications are subject to modification to accommodate individuals with disabilities.
Cambrex is committed to equal opportunity and affirmative action, considering all qualified applicants without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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