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* 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.
* 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
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
o Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
o Presentation skills
o Escalate issues professionally and on a timely basis
* Decision Making skills
* Teamwork and Coaching others
* Negotiation and Influence skills
* Problem solving skills
o Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
o Ensures compliance within regulatory environment
o Develops solutions to technical problems of moderate complexity
o Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
o Interprets generally defined practices and methods
o Able to use statistical analysis tools to perform data trending and evaluation
o 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
o Works under minimal direction
o Work is guided by objectives of the department or assignment
o 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
o Demonstrated leadership and communication skills
o Auditing documentation and operation process
o Demonstrated ability to interact with regulatory agencies Specific Job Duties:
o Perform analytical testing as a main priority with efficiency and accuracy
o With a high degree of technical flexibility, work across diverse areas within the lab
o Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
o Report, evaluate, back-up/archive, trend and approve analytical data.
o Troubleshoot, solve problems and communicate with stakeholders.
o Initiate and/or implement changes in controlled documents.
o Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
o Write protocols and perform assay validation and equipment qualification/verification.
o Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
o Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
o Approve lab results
o May participate in lab investigations.
o May provide technical guidance.
o May train others.
o May contribute to regulatory filings.
o May represent the department/organization on various teams
o May interact with outside resources
o Basic Qualifications
o Bachelors degree in a science discipline
o Biopharmaceutical QC experience in a microbiology lab
o Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
o Preferred Qualifications
o 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.
o Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
o Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
o Skills
o Take initiative to identify and drive improvements
o 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
o Decision Making skills
o Teamwork and Coaching others
o Negotiation and Influence skills
o 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
o Project Management and organizational skills, including ability to follow assignments through to completion
o Competencies
o Technically strong background in microbiology and aseptic manufacturing
o Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage
o Experience with Regulatory inspectors and interacting with inspectors desirable
o 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
o Refers to technical standards, principles, theories and precedents as needed
o May set project timeframes and priorities based on project objectives and ongoing assignments.
o Recognizes and escalates problems
+ Demonstrated leadership and communication skills
+ Auditing documentation and operation process
+ Demonstrated ability to interact with regulatory agencies
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Biotechnology Research and Pharmaceutical Manufacturing
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