Job Description

Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.

FUNCTIONS

• Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies.
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Approve lab investigations, Lead audit teams
• May serve as subject matter expert to develop technical training.
• May perform routine work in a specific area of responsibility as necessary.
• Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.
• May resolve issues with outside resources.
• Performs special projects as requested by supervisor, may supervise employees as necessary to meet technical requirements.

COMPETENCIES/SKILLS

• Excellent communication skills, facilitation and presentation skills.
• Excellent technical writing skills.
• Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
• Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
• Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
• Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
• Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
• Extensive knowledge and application of GMPs/CFRs.
• Skill in evaluating and documenting according to Company and various guidelines.
• Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.

Requirements

• Doctorate OR
• Masters + 2 years of directly related experience OR
• Bachelors + 4 years of directly related experience OR
• Associates + 8 years of directly related experience OR
• High school/GED + 10 years of directly related experience.

• Preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management and Quality processes. Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering.

Preferred Qualifications

• Strong Technical Writing (English and Spanish) mainly focuses
• Strong knowledge in Microsoft Excel as a Tool for Data Analysis
• Good Communication skills
• Project Management
• Knowledge in Computer System and Method Validation (Experience preferable)
• Strong knowledge and experience with quality process management
• Knowledge on equipment validation and troubleshooting (Experience preferable))
• Agile on prioritization of critical tasks
• Ability to develop inspection or qualification protocols in a short timeframe period.
• Strong negotiation skills
• Usage of KNEAT platform and Kaye validator (Experience Preferred)

Benefits

• Administrative Shift
• 6-months contract