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QC Analyst

Company Name:
MedImmune
Job Description
Performs selected quality control testing activities, dependent upon assigned area, including the following:
Responsible for conducting raw materials, in process, stability and finished product testing according to standard operating procedures.
Completes appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms.
Calibrates and maintains laboratory equipment according to standard operating procedures.
Identifies and troubleshoots equipment problems.
Enters data evaluated for compliance to specifications and reports abnormalities.
Maintains lab instrumentation according to maintenance schedules.
Maintains supply levels to support performance of assigned duties.
Reads, understands, and follows SOPs and complies with cGMPs.
Owns Level 1 Non-comformance 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 requiring an in-depth
knowledge of scientific methods and techniques.
Applies knowledge of good manufacturing practices and
good laboratory practices on a daily basis.
Adheres to Company safety procedures and guidelines on a daily
basis. Depending on demonstrated ability, the analyst will assist in
execution of protocols and laboratory studies required to support
QC investigations, method validation, and stability studies, as well
as preparation of technical reports and data summaries.
Follows all safety regulations as indicated in the MedImmune Policies
and Procedures.
Performs laboratory testing as assigned and per schedule.
Maintains training >95% completed on time, with 100% completed prior to performing any related analysis, etc.
Owns Level 1 Non-Conformance records.
Owns simple VSCR and CAPA records.
Executes tech transfer and other studies for basic/platform laboratory
test methods.
Performs review of logbooks, chart recorders, etc across groups.
BSP
Position Requirements
Position:
Be able to plan and carry out laboratory operations efficiently and effectively. Must be able to maintain accurate records of all experiments and data. Critical thinking and attention to details required. Must be a team player and customer oriented. Candidate will be working under supervision but level of independence should increase with time. QC or GMP experience a plus.
Education:
Bachelors: Scientific / Biotech / Pharmaceutical field of study, preferred 0-5 years experience.
Additional Notes
Self-motivated. Multi-tasking, excellent written and oral communication skills desired.
Title: QC Analyst
Location: MD, Frederick
Req ID: 7741
Position Category: Operations - Quality

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