Career Category
QualityJob Description
Specific Job Duties:
- Perform Sterility testing as a main priority with efficiency and accuracy
- With a high degree of technical flexibility, work across diverse areas within the lab
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- 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 assay 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
- May participate in lab investigations.
- May provide technical guidance.
- May train others.
- May contribute to regulatory filings.
- May represent the department/organization on various teams
- May interact with outside resources
Basic Qualifications
- Bachelors 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 in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
- Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Skills
- Take initiative to identify and drive improvements
- Excellent verbal and written communication skills
- Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
- Presentation skills
- Escalate issues professionally and on a timely basis
- Decision Making skills
- Teamwork and Coaching others
- Negotiation and Influence skills
- Problem solving skills
- Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
- Ensures compliance within regulatory environment
- Develops solutions to technical problems of moderate complexity
- Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
- Interprets generally defined practices and methods
- Able to use statistical analysis tools to perform data trending and evaluation
- Project Management and organizational skills, including ability to follow assignments through to completion
Competencies
- Technically strong background in microbiology and aseptic manufacturing
- Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage
- 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
- Demonstrated leadership and communication skills
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies
Specific Job Duties:
- Perform analytical testing as a main priority with efficiency and accuracy
- With a high degree of technical flexibility, work across diverse areas within the lab
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- 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 assay 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
- May participate in lab investigations.
- May provide technical guidance.
- May train others.
- May contribute to regulatory filings.
- May represent the department/organization on various teams
- May interact with outside resources
Basic Qualifications
- Bachelors 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 in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
- Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Skills
- Take initiative to identify and drive improvements
- Excellent verbal and written communication skills
- Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
- Presentation skills
- Escalate issues professionally and on a timely basis
- Decision Making skills
- Teamwork and Coaching others
- Negotiation and Influence skills
- Problem solving skills
- Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
- Ensures compliance within regulatory environment
- Develops solutions to technical problems of moderate complexity
- Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
- Interprets generally defined practices and methods
- Able to use statistical analysis tools to perform data trending and evaluation
- Project Management and organizational skills, including ability to follow assignments through to completion
Competencies
- Technically strong background in microbiology and aseptic manufacturing
- Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage
- 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
- Demonstrated leadership and communication skills
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies
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