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
.