Sr Associate QC - Microbiology (24/7 Shift)

• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

• Approve lab results.

Basic Qualifications:

• Bachelor's degree in a science discipline

• Biopharmaceutical QC experience in a microbiology lab

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products .

Preferred Qualifications:

• Experience working in an aseptic cleanroom performing Environmental Monitoring

• Proficient in the use of LIMS & LMES

• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

• Biopharmaceutical QC experience in a microbiology lab

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Competencies

• Technically strong background in microbiology and aseptic manufacturing

• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage

• Flexibility - the EM role often encounters changing priorities on a daily basis

• Problem solving skills

• Experience with Regulatory inspectors and interacting with inspectors desirable

• Demonstrated ability to work independently and deliver right first time results

• Works under minimal direction

• Work is guided by objectives of the department or assignment

• Follows procedures

• Refers to technical standards, principles, theories and precedents as needed

• May set project timeframes and priorities based on project objectives and ongoing assignments.

• Recognizes and escalates problems

• Auditing documentation and operation process

• Demonstrated ability to interact with regulatory agencies.

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