Description:
Uses scientific education and experience to perform complex laboratory testing within a good manufacturing practices environment to generate results. Interprets data output to determine conformance to specifications. Acts as a senior team member of a small group of laboratory analysts led by the QC Laboratory Group Leader in one of the following disciplines: API Laboratory Operations, Finished Goods Laboratory Operations, Raw Material/ In-Process Laboratory Operations, Sterilization Technology Operations, and Microbiological Operations.
Responsibilities
- Performs complex analytical, microbial, or sterilization test methods as written and performs data verification of laboratory results to support product and material release.
- Understands multiple and complex laboratory techniques and principles and can independently trouble-shoot and resolve analytical techniques and instrument issues.
- Develops, implements and ensures improvement ideas are completed to facilitate team objectives.
- Can readily and independently work in all QC Laboratory test locations (and potentially other operational sites) as assigned and can effectively perform a multitude of laboratory techniques for which they are trained on without error while adjusting to unforeseen technical or logistical obstacles to accomplish assignments.
- Budgets their time independently and effectively to carry out assigned tasks and makes recommendations for improvement. Takes initiative to be a key player in team activities and decision making.
- Recognizes obstacles to technical or process related issues and can independently and effectively resolve them. Consistently achieves commitments despite obstacles.
- Accepts full responsibility to complete assigned tasks as committed and proactively identifies and performs new tasks outside area of responsibility.
- Takes ownership of special projects as needed to support overall laboratory needs and requirements.
- Offers analytical guidance and expertise to less experienced analysts to meet laboratory needs.
- Interfaces with regulatory agencies during audit activities as needed.
Qualifications
- Bachelor’s Degree with at least 6 years of laboratory experience; or Associate’s Degree with at least 8 years of laboratory experience; or High School Diploma with at least 10 years of directly related lab experience.
- Good interpersonal and communication skills.