- Under general supervision investigates the growth and characteristics of microscopic organisms such as bacteria, algae and fungi. Designs, conducts and interprets biological experiments to support development programs and identifies biological pathways and agent.
- Provide biological scientific support to technology and product development. Review scientific and technical summaries, and provides recommendations for potential business applications.
- Following SOPs and special test designs; analyzes test data and completes required documentation, initiates and manages QA test method improvements, equipment, and process validations.
- Serve as a team member in the QA Microbiology laboratory; Leads in the implementation of validation and test methods and test correlations.
- Prepares and executes all protocols and reports for validation work.
- Will coordinate all validation activities by constant communication with related departments and personnel; oversees and reviews validation area processes and procedures.
- Responsible for preparing and analyzing timelines and reports to ensure project deliverables arrive on time and within budget.
- Responsible for providing day-to-day strategic guidance and direction to the Laboratory Technicians regarding validation and process control procedures.
- Strong Technical writing skills is a mandatory.
- Clean and maintain laboratory areas and equipment according to procedures.
- Individual is accustomed with basic and advanced scientific principles and must have laboratory experience.
- Can follow written direction and maintain a laboratory notebook.
- Will update SOPs and Work Instructions as directed. Being able to work independently is of the utmost.
- Has good communication skills and is computer literate.
- Also responsible for performing more complex laboratory functions and study support.
- This role will also include documentation improvement, implementation of new equipment upgrades and technology.
- Sets up, operates and maintains laboratory instruments, monitors experiments, makes observations, calculates and records results, and often develops conclusions.
- Perform all laboratory processes in accordance with cGMPs, SOPs, TMs safety rules and project/task schedule.
- Support and coordination of test analysis for the Regulatory Affairs, Manufacturing and R&D departments.
- Performs QC/equipment maintenance, understands lab safety involving potentially infectious bio-waste and is a team player.
- Will investigate testing abnormalities and implement non-conformance reporting and corrective action plans.
- Performs environmental monitoring testing and other special projects by supporting substaining activities in environmentally controlled areas as well as area expansions.
- Minimum a 4 year degree in the sciences (preferential in Microbiology/Engineering/Chemistry/Biochemistry) with 3-5 years’ work experience with a proven track record in Equipment Validation and general laboratory techniques within the medical device and/or pharmaceutical industry or master's degree in engineering and 2-3 years of experience in the field or in a related area.
- Familiar with standard concepts, practices, and procedures within a particular field.
- Technical writing is a necessary for creation of required reports, specifications, summarizations and other technical documentation.
- GMP, GLP, GDP, FDA, and OSHA knowledge is required
Kind Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - 732-662-7964
