This position is primarily responsible for independently performing quality control analytical laboratory testing. Perform training and assist in laboratory operations, planning and special projects.
- Perform complex, routine, and non-routine physical and chemical tests and assays on raw materials, active pharmaceutical ingredients, in-process and finished products, using various wet chemical, physical and instrumental techniques.
- Independently plan and execute testing to meet established deadlines. Assist in planning testing to meet deadlines.
- Ensure that the laboratory testing techniques and documentation comply with GMPs, SOPs, and are of the highest integrity and accuracy.
- Record data and results as specified in documentation procedures.
- Ensure that all necessary information is entered into the appropriate databases for trending and capacity modeling purposes.
- Review and approve data and results as assigned.
- Use the correct PPE and follow all applicable safety procedures.
- Assist in performing effective and timely investigations of out-of-specification and out-of-trend data and communicate to manager and affected departments.
- Monitor metrics or KPIs and communicate information and recommendations to QC Manager.
- Communicate with other departments to coordinate activities.
- Initiate, author and revise test procedures, SOPs, technical reports, and other documents.
- Maintain and improve laboratory efficiency by implementing improvements, new techniques, training, new processes and/or improvements to work flow.
- Assist in special projects or other tasks as deemed necessary based on personal qualifications, business needs and QC management’s discretion.
Training or Experience:
- At least 5 years of pharmaceutical QC Laboratory testing experience in a cGMP-regulated laboratory environment.
- Knowledge of GMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations.
- Excellent oral and written communication skills.
- Expertise in Microsoft Word and Excel.
- Strong troubleshooting and investigation skills.
- Thorough knowledge of laboratory test procedures and instrumentation, especially HPLC; USP/NF methodology; relevant regulatory requirements. In-depth knowledge of scientific concepts.
- Ability to read and interpret test procedures, manuals, technical documents or instructions in mathematical or diagram form, SOPs and governmental regulations. Ability to summarize and explain such documents to the QC Laboratory staff as well as to non-scientists.
- Ability to apply concepts such as fractions, percentages, ratios, proportions, and statistics to practical situations.
- Ability to perform mathematical calculations used for assigned testing and to assist more junior staff in performing calculations.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to report data and observations accurately, both in writing and verbally.
- Minimum of a BS Degree in Chemistry or related discipline