QA Compliance Investigator Allendale, NJ ref
Skills : Batch records review, Documentation management, CAPA, Non-conformance, Deviations, cGMP, FDA.
Referral reward:$250 Job type:Direct hireJob function:Quality AssuranceIndustry:BiotechnologyExperience level:Mid-seniorEducation level:Bachelor’s degreeJob classification:TechnicalLocation:Allendale, NJZip code:07401Skills:Batch records review, Documentation management, CAPA, Non-conformance, Deviations, cGMP, FDAExperience required:5 YearsRelocation assistance:NoVisa requirement:Only US citizens and Greencard holders,EAD cards
QA Compliance Investigator
This position will report into the (Associate) Manager of 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.
Essential Functions and Responsibilities
Below is the summary of the role responsibilities. This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice
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.
B.S in biological sciences or other relevant field of study.
Minimum 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
This job has no supervisory responsibilities.
Minimum Required Training (optional)
SOP & WI training
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.
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.
Wheel-o-Vator available for use.
Small breakroom available. No on-site cafeteria available.
Sedentary work. 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.
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.