Full Job Description
Independently performs routine and non-routine testing. Performs laboratory testing within a GMP environment in support of one or more of the following areas; raw materials, in-process product, final Bulk product, stability, and/or validation. Analyzes test data, evaluates results and forms conclusions with minimal outside input. Is able to recognize laboratory technique or instrumental events that could impact the integrity of the test data. Recognizes and resolves simple to moderately complex technical problems. Writes procedures with minimal guidance. Works under the general guidance of a supervisor but can effectively manage their own time to ensure timely completion of assigned duties. Trends data to support assay performance. Effectively writes all types of exception reports. Responsibility includes technical writing and execution of test method to support new product introduction into Quality Control.
Responsibilities
347Performs more complex test methods as written to support product/material release with minimal error.
347Understands laboratory techniques and principles performed.
347Interprets experimental data for conformance with product/material specifications.
347Understands, implements and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
347Assists with writing and performs validation assays per approved protocols.
347Can effectively perform a multitude of laboratory techniques for which they are trained on with minimal error.
347Make recommendations for process improvement.
347Writes/revises procedures as necessary and provides support for department.
347Develops and maintains trend reports, backlog report, and document error reports which support departmental performance.
347Authors all types of Investigations and deviations effectively. Assist in troubleshooting assays.
Qualifications
347BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree.
3475-8 years of related work experience
347Maintains their certifications as needed for assigned job tasks.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
347The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
347We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
347This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.