Quality Assurance Compliance Specialist
Minaris Regenerative Medicine
Allendale, New Jersey, United States
Job type: fulltime
Job industry: Science & Technology
Quality Assurance Compliance Specialist
This position will report into the (Associate) Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems 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 provide guidance through all stages of the investigation / CAPA processes.
- Develops and communicates investigation strategy to key stakeholders.
- In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log
- Reviews and approves investigations and CAPAs;
- Conducts weekly status update meetings with cross functional departments and other stakeholders.
- Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis.
- 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.
- Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
- Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
- Written Communication: able to write clearly and succinctly in a variety of communication settings and styles.
- Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
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.