Quality Assurance - Compliance Investigator

Minaris•Allendale, NJ

1d•Onsite

About The Position

Responsible for performing Quality Compliance and Quality System activities in support of Quality Management Systems and/or client procedures, including but not limited to, document management, investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality System 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.

Requirements

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
Resolves and assesses a wide range of issues in creative ways and suggests variations in approach.
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 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
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
This role operates within a professional office environment of a manufacturing operations plant.
This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
Seating is mixed and includes open space seating, cubicle, and office space.
Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
Identifies, recruits, and retains top-notch talent.
Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
Develop employees to meet both their career and organizational goals.
Builds strong customer relationships and delivers customer-centric solutions.
Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
Comfortable working in ambiguous situations and adaptable to change.
Must model the highest degree of moral and ethical behavior and maintain confidential information.
High degree of autonomy and strong decision-making skills.
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.
Must be able to work in an office environment with minimal noise conditions.
Must be able to work in Lab setting with Biohazards /various Chemicals
Must be able to wear appropriate PPE
Must be able to work in environment with variable noise levels
Ability to stand /Sit/walk for long periods of time
Clarity of Vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures high to freezing
Inside/outside working conditions
If selected to become qualified for visual inspection, the employee must pass an eye exam including corrected or uncorrected 20/20 vision, ability to pass a color blindness test, and ability to pass a depth perception test
Employee will work with moderate noise levels.
Employee will perform tasks while experiencing numerous interruptions.
Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight.
The work environment is fast paced.
This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct.
Off-shift, weekend and overtime duties may be required.
While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.

Nice To Haves

strong focus in the manufacturing and/or testing of biologics preferred
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

Responsibilities

Liaises with relevant functional groups (Operations, Facilities, QA, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes.
Develops and communicates investigation strategy to key stakeholders.
Collects necessary information from appropriate department to close investigations and CAPAs 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 controls, as necessary.
Adheres 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 assignments as necessary.
Support in agency, internal and/or client audits.