Analytical Report Reviewer II
4 weeks ago
Position Overview:
The role involves the independent evaluation of various technical documents and raw data produced in laboratory operations.
Key Responsibilities:
• Conduct thorough reviews of all standard technical documents, including batch testing, stability assessments, and method validation, ensuring high-quality output delivered within established timelines.
• Confirm adherence to test methods, protocols, and Standard Operating Procedures (SOPs) by laboratory personnel.
• Assess the integrity and traceability of all generated and reported data.
• Collaborate with scientists and technicians to rectify any identified discrepancies in accordance with Good Manufacturing Practices (GMP).
• Inform the department supervisor or manager of any omissions, incomplete results, or other anomalies.
• Travel to various sites may be required based on business needs.
• Uphold a safe working environment and report any potential hazards.
• Participate in alternating or rotating shifts as necessary.
Qualifications:
Education:
Bachelor's degree in Chemistry or a related scientific field.
Experience:
A minimum of three years of experience in pharmaceutical analytical development is required. Previous experience in document review is preferred. Familiarity with current ALOCA principles is essential. Proficiency in Empower software is necessary, along with the ability to work afternoon shifts.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
A foundational understanding of common analytical technologies such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, titration, and raw material testing is required. Strong written and verbal communication skills are essential. A solid understanding of Good Manufacturing Practices, International Conference on Harmonization (ICH), and FDA requirements is expected. Candidates should demonstrate strong organizational skills and attention to detail. Experience with GMP chromatography, particularly with EMPOWER, is advantageous. Direct experience in a GMP environment within the pharmaceutical sector is preferred. The ability to meet deadlines and prioritize tasks effectively is crucial. Proficiency in Microsoft Office applications is necessary.
Standards and Expectations:
Adhere to all Environmental Health & Safety Policies and Procedures. Collaborate effectively with team members, demonstrating positive teamwork principles to achieve project and departmental goals. Execute all responsibilities in strict compliance with quality systems SOPs and GMP. Maintain a clean and organized workspace. Engage actively in departmental systems to ensure efficient workflow. Maintain client and patient awareness at all times. Understand Key Performance Indicators and strive to enhance team performance by identifying areas for improvement and engaging in problem-solving. Exhibit a positive attitude and adaptability to changes in priorities and work methods. Proactively identify opportunities for procedural improvements and communicate potential risks to timelines.
Physical Requirements:
This position requires ordinary ambulatory skills and physical coordination sufficient to navigate laboratory environments. The ability to stand, walk, stoop, kneel, and crouch for extended periods is necessary. Candidates should be able to lift, carry, and move light to medium weights (10-35 pounds) and possess dexterity for typing and operating equipment. Visual acuity for prolonged periods is required, along with the ability to communicate effectively.
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