Quality Control Analyst
Proclinical is currently recruiting for a Quality Control Analyst with a pharmaceutical company located in Brooklyn Park, MN.
- Perform activities for general lab readiness, laboratory equipment qualification, and method transfers.
- Conduct critical biological test methods including samples generated for in-process, drug substance, and stability.
- Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS and Empower).
- Independently prioritize and perform routine and non-routine methods requiring precise analytical skills and understanding of biology and chemistry principles.
- Demonstrate an in-depth theoretical understanding of laboratory operations, systems, and methods.
- Complete all testing, including special project / protocol testing in a timely and appropriate manner.
- Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
- Independently exercise judgment for broadly defined practices, procedures, and policies to select methods, techniques, and evaluation criteria. Obtains results, troubleshoots problems, and formulates solutions.
- Decisions have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.
- Serve as a point person for particular assays and/or equipment and systems.
- Work within laboratory environment for extended periods of time, conducting analytical tests, reviewing analytical data, maintaining laboratory materials and instruments and other laboratory functions as required
- Perform laboratory instrument qualification.
- Initiate and own deviations, CAPAs, and change controls within the electronic Quality Management System.
- Drafts studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors.
- Revises and authors new SOPs and study documentation.
- Receives minimal instruction on new assignments.
- Provides mentoring, training and may serve as Lab Lead to direct work of lower level QC Analysts.
- Coordinates projects within the QC department.
- May interact as a technical resource with collaborators, stakeholders, and vendors.
- May perform equipment maintenance and calibrations as required.
- Complete mandatory training within required timeframe.
- Perform other duties as assigned.
Skills and Requirements:
- Bachelor's or Master's Degree in any Life Sciences with relevant laboratory coursework
- 7+ years of relevant experience preferred.
- Preferred strong background in High Performance Liquid Chromatography (HPLC) and Ultraviolet-Visible Spectroscopy (UV-Vis).
- It is desirable that the candidate has experience with Total Organic Carbon (TOC) analysis and Capillary Electrophoresis (CE), but not required.
- The ideal candidate would have experience working in a commercial Pharmaceutical Quality Control laboratory.
- Previous industry experience in a regulated environment highly desired.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Must have understanding of laboratory instrumentation.
- Must be able to communicate effectively with managers and peers.
- Must be able to read, write, and converse in English.
- Must have basic computer skills. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service.
- Good interpersonal skills and able to work effectively and efficiently in a team environment.
- Knowledge of cGMP manufacturing preferred.
- Knowledge of basic chemical and biological safety procedures.
- Must display eagerness to learn and continuously improve.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
If you are having difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.