Full-time, Permanent
This position will be reporting to the Quality Assurance department and supports the GMP Analytical laboratory. The GMP Analytical laboratory provides analytical services to both GMP and non-GMP manufacturing by supporting development and validation of analytical test methods, evaluation and testing of cleaning samples, raw materials, process intermediates, final APIs, and final dosage forms, characterizing/qualifying Reference Standards, and performing Stability evaluations. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, and regulatory requirements.
Responsibilities:
- Ensures the quality of laboratory data and reports. Efficiently and effectively reviews chromatographic/other data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, and Good Manufacturing Practices (GMP).
- Must be able to understand and interpret analytical data (chromatographic and other). Scrutinizes and fully fathoms routine and non-routine testing/other data in order to ensure compliance, accuracy, and completeness of work as well as veracity of results based on documented data.
- Must be able to critically and in detailed fashion review/verify Reports, SOPs, Specifications, Analytical procedures, etc. Example: Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
- Must be able to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
- Must be able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Organizes workflow and tasks to maximize efficiency (e.g., prioritize review/writing based on client/business needs, etc.).
- Demonstrated ability to work with others at all levels of the organization and have basic knowledge of computers and industry-related software.
- Ability to work effectively under pressure to meet deadlines
- Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines.
Minimum Requirements:
- Bachelor’s degree in Chemistry, Biology, Microbiology, or closely related discipline, and 4 years relevant pharmaceutical laboratory/analytical experience, including a minimum requirement of 2 years of data review experience.
- Broad background in analytical methodology, strong comprehension, and demonstrated skills in review of analytical and compliance oriented data and documentation.
- Thorough knowledge of SOPs, cGMPs, and Federal Regulations
- Prior HPLC/GC/Other Instrumental experience is required.
- Certified Quality Auditor or similar is a strong plus.
- Hands-on experience in technical writing is a plus.
Other Experience/Skills:
- In-depth work experience in an analytical contract laboratory environment is a strong positive.
- Experience in stability study performance/evaluation is helpful.
- Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
- Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.