QA/QC

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Job description

Duration: 6+ months initially, with a possibility for extensions or Full-Time conversion.

Shift: This would be a standard Monday.

Job Description:

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

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


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


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


• Calibrates and maintains laboratory equipment according to standard operating procedures.


• 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


• Applies critical thought to solving problems.


• 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 performing any related analysis, etc


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

Requirements:

• Be able to plan and carry out laboratory operations efficiently and effectively.


• 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:

• BS/MS in biological or chemical science (chemistry, or biochemistry, etc.).


• BS (0-3years) preferably in pharmaceutical industry.

Pluses:

• Hands on experience with HPLC, GC or capillary electrophoresis desired.


• Self-motivated. Multi-tasking, excellent written and oral communication skills desired.

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