Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. This role will support manufacturing operations, as such some extended hours, shift and weekend work may
be necessary as required.
Job duties are as follows but not limited to:
* Endotoxin testing of water, in-process and drug product release samples
* Bioburden testing of water & in-process drug product samples
* Sterility testing
* Water sampling
* Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
* Writing technical reports
* 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 routine/ non-routine methods and procedures with a large variety of assays.
* Report, evaluate, 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.
* 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.
* Review and 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
* 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
* Experience working in endotoxin, bioburden or sterility testing
* Proficient in GMP systems such as LIMS Labware & LMES
* Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), 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
* Technically strong background in microbiology and aseptic manufacturing
* Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
* Flexibility - the role often encounters changing priorities (also required to work weekend on call - Rota system)
* Demonstrated ability to work independently and deliver right first time results
* Works under minimal direction, Recognizes and escalates problems
* 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.