
Executive Quality Control
4 weeks ago
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.
What You Will Achieve
In this role, you will:
- Perform routine and non-routine analysis of raw materials, in-process samples, and finished products.
- Independently operate and maintain analytical instruments including UV-Vis Spectrophotometer, IR Spectrometer, HPLC, TLC, Photodocumentation System, and Tiamo System.
- Execute dissolution testing techniques and interpret results accurately.
- Troubleshoot and resolve analytical issues, especially related to HPLC systems.
- Ensure timely planning and execution of QC activities.
- Escalate issues promptly to relevant stakeholders to avoid delays in production or release.
- Perform data calculations with precision and ensure accurate documentation.
- Maintain compliance with GMP, GLP, and other regulatory standards.
- Participate in method development and validation activities.
- Support audits and inspections by providing necessary documentation and explanations.
- Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments.
- Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
- Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
- Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
- Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database, and generate EMS reports.
- Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.
- Required Skills & Competencies:
Strong analytical and problem-solving skills.
- In-depth knowledge of HPLC troubleshooting and data interpretation.
- Proficiency in handling UV, IR, TLC, Photodocumentation, and Tiamo systems.
- Good understanding of dissolution techniques and their applications.
- Ability to plan and prioritize tasks effectively.
- Excellent documentation and communication skills.
- Ability to work independently and collaboratively in a team environment.
Here Is What You Need (Minimum Requirements)
- Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
- Demonstrated technical skills in method validation and testing
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
- Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
- Excellent organizational skills and strong ability to multi-task
- Strong written and verbal communication skills
- Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
Bonus Points If You Have (Preferred Requirements)
- Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography) techniques
- Proven track record in leading continuous improvement projects
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
- Strong problem-solving skills and attention to detail
- Ability to manage multiple priorities and meet deadlines.
- Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels
- Adaptability and willingness to learn new techniques and procedures
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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