Our Biotech, Cell and Gene Therapy Client is seeking a QC Analytical Compliance Investigator for their Allendale, NJ location.  This position will report into the Associate Manager Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. 

• Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes.
• Conduct investigation and identify true root cause using appropriate tools.
• Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates.
• Reviews and approves investigations and CAPAs when required;
• Collaborate with cross functional department to develop and track CAPA plans.
• Prepares and issues change control as necessary.
• Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures.
• Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
• Performs supplemental investigations and/or participates in project teams or assignment as necessary.
• Support in agency, internal and/or client audits.
• Other duties as assigned. 

REQUIREMENTS 

• B.S biological sciences or other relevant field of study.
• 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
• Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
• Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
• Familiar with FDA, ISO, and other regulatory agency guidelines.
• Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
• Working knowledge and technical understanding of aseptic manufacture of biologics preferred. 
• Experience in both clinical and commercial manufacturing is preferred.
• Experience in supporting health authority inspections and/or client audits preferred.
• Relevant computer skills: Microsoft Office, Outlook
• Detail-oriented and organized
• Analytical and problem-solving skills
• Good written and oral communication skills
• Ability to multi-task and be adaptable
• Flexible and able to adapt to company growth and evolving responsibilities
• Ability to work independently and with a team
• Strong Project Management and organization skills
• Trained in: GXP, SOP & WI training, Safety, Working Environment
• Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.
• Must be able to work in a team-oriented environment.
• Must be able to work occasional weekends, nights, and/or holidays as required/necessary.
• Wheel-o-Vator available for use. 

Physical Requirements 

• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
• Must be able to handle the standard moderate noise of the manufacturing facility.
• Must be able to work in open floor plan environment and may work in close proximity to others.
• Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
• Occasional prolonged periods of standing during times of observation (up to 35% of the time).
• Must be able to utilize proper personal protective equipment (PPE) to handle human specimens, gases, corrosive chemicals, etc.
• Able to utilize equipment in manufacturing are as well QC laboratories.
• Understanding and comprehension of quality system applications. 

Other Duties 

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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