Sr Associate QC - Microbiology (24/7 Shift)

Career Category

Quality

Job Description

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

Specific Job Duties: 

• Environmental Monitoring of Grade 8/9 Cleanrooms
• Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
• Reading of Environmental Monitoring Plates
• Bioburden testing of water & disinfectants
• Writing technical reports
• Water sampling
• Testing of In Process samples such as Density & pH
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform validation and equipment qualification/verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• 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 

• Minimum three years' Biopharmaceutical QC experience in a microbiology lab, working as part of an Environmental Monitoring team who directly support manufacturing in a Grade A/B area
• 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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