Our leading, Global Contract Development and Manufacturing Organization Biotechnology client is seeking a Quality Assurance Associate I who will be responsible for performing Quality control activities with minimal supervision of daily tasks in support of company and client procedures. Procedures are expected to be performed with precision and accuracy and demonstrate a high level of documentation accuracy and clarity. Compliant with all applicable SOP’s and good documentation practices as well as cGMP and cGTP requirements. Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify your manager. Document all corrective actions taken when test systems deviate from the laboratories established performance specifications. 

• Perform the accurate execution of test methods and procedures
• Maintain inventory of QC materials and lab supplies, including monitoring and ordering
• Perform maintenance, monitoring, and troubleshooting of pertinent equipment
• Perform reagent and media preparation
• Compliant with all applicable SOPs and good documentation practices(GDP) as well as cGMP/GCTP requirements
• Conduct test, review and release test results for products or materials
• Perform and assist in equipment qualification and method validations as needed
• Perform state proficiency testing and/or client proficiency testing under direct supervision as applicable
• Investigate Out of Specification (OOS), Out of Trend (OOT) and/or non-conforming test results
• Assist in investigations, and preparation of deviation reports, with input from the manager or lead, in a timely manner and implements corrective actions and preventive actions
• Packaging and shipping samples to contracted Laboratories for testing and/or to Clients 

REQUIREMENTS 

• Relevant college degree, Medical Technologist license or equivalent
• Minimum of 0-1 years’ applicable experience in a clinical laboratory, microbiology, hematology, blood banking, immunology or QC laboratory preferably in a cGMP/cGTP environment.
• Basic knowledge of Flow Cytometry experience preferred
• Must be proficient in QC test methods/procedures and use of the QC lab equipment
• Working knowledge of GxP regulations and standards
• Working knowledge of quality systems: Change control, Deviations, CAPA, etc.
• Relevant computer skills (Microsoft Office, Outlook)
• Meticulous (Detail-oriented)
• Organization skill
• Strong collaborative skills
• Analytical and problem-solving skills
• Good written and oral communication skills
• Flexible and able to adapt to company growth and evolving responsibilities
• Ability to manage multiple tasks and changing priorities
• Ability to work independently and with cross functional teams
• Time management skills essential 
• Must have the ability to work in a team-oriented environment and with clients
• Must be able to work during the weekend, holidays and as required by the company
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
• Must have the ability to work in the cleanroom environment for extended period of time
• Must have the ability to work with specialized equipment
• Must be able to handle the standard/moderate noise of the manufacturing facility. 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. 

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey.

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