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Location:
Frederick, Maryland, United States
Job reference: R-033084
Posted date: Jul. 31, 2018
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QC Analyst

Scope

Performs selected quality control testing activities, dependent upon assigned area, including the following:

• Responsible for conducting raw materials, in process, finished product and stability testing according to standard operating procedures.

• Completes appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms.

• Identifies and troubleshoots equipment problems.

• Enters data evaluated for compliance to specifications and reports abnormalities.

• Reads, understands, and follows SOP’s and complies with cGMP’s

• Owns Level 1 Non-conformance records and simple VSCR and CAPA records.

• Supports preparation of validation protocols, executes experiments, and provides data for validation reports.

• Responsible for writing new standard operating procedures or revising existing documentation.

• Applies critical thought to solving problems.

• Works on problems requiring an in-depth knowledge of scientific methods and techniques.

• Executes tech transfer and other studies for basic/platform laboratory test methods

• Performs review of logbooks, chart recorders, etc. across groups

Knowledge

Complete knowledge of the job.  Full understanding of the general and detailed aspects of the job.  Frequent use and application of technical standards, principles, theories, concepts, and techniques associated with specific tasks.

Problem Solving

Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.  Ability to deal with problems involving a few concrete variables in standardized situations.

Freedom To Act

General supervision and  instructions given for routine work.  Detailed instructions given for new activities or special assignments.

Impact

Errors can be detected and corrected but may delay lot release.

Interpersonal Communication

Contacts are typically with individuals within own department and occasionally with contacts outside own organization.  Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Supervisory / Management Skills

N/A

Preferred Education and Years of Experience

Bachelors:  Scientific / Biotech / Pharmaceutical field of study, preferred 0-5 years experience

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QC Analyst
Quality

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