QC Microbiology Compliance Investigator

1 month ago

Allendale, United States Minaris Regenerative Medicine Full time
Job DescriptionJob Description

QC Microbiology Compliance Investigator


At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.


The QC Microbiology Compliance Investigator leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance.

Essential Functions and Responsibilities

Below is the summary of the role responsibilities. This is not 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.

Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations.
Drive investigations to true root cause using appropriate investigation tools.
Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
Define and implement effective preventative actions to prevent recurrence.
Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
Collaborate with cross-functional teams to develop and track CAPA plans.
Identify and create appropriate trending rules that trigger corrective actions.
Analyze process data and evaluate trends to identify major improvement opportunities.
Effectively utilize change management approach.
Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process.
Manage CAPA plans and implementation.
Provide communication plan for on-going deviations & CAPA’s.
Effectively create and communicate CAPA plan to responsible parties.
Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
Ability to abide by quality standards.

Qualifications

Bachelor of Science in a Quality / Process related field or equivalent experience.
3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Must have technical experience writing and assessing deviations, investigations, and Out of Specifications
Must be able to analyze data/information and to assess and resolve complex problems
Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing
Knowledge of operational processes and controls in non-sterile and sterile operations
Experience using e-Quality Management Systems preferred.
Relevant IT skills (able to work with Visio, Microsoft Project and Excel)

Competencies/Candidate Profile

Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
Analytical and problem-solving skills
Strong written and oral communication skills
Flexible and able to adapt to company growth and evolving responsibilities
Integrity, accountability and strong dedication to regulatory compliance
Continuous improvement mindset
Ability to work effectively as a team and independently.

Supervisory Responsibility

This job has no supervisory responsibilities.

Quality Requirements

Build Quality into all aspects of your work by maintaining compliance to all quality requirements.

Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).

Attend all required Quality & Compliance training at the specified interval.


Minimum Required Training to be Completed within the First 90 Days of Hire

Must understand and adhere to Good Documentation Practices (GDP)

Maintain 100% training records for all required training.

Valid driver’s license and clean driving record

Working Environment

Must have the ability to work in a team-oriented environment and with clients.

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.

Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

Must have the ability to work with specialized equipment.

Must be able to handle the standard/moderate noise of the manufacturing facility.

May work with hazardous materials and chemicals.

The work environment requires gowning, hair net, safety glasses, gloves, and foot coverings.

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.

Physical Requirements

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

This role is sedentary. An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.

Gowning proficiency as needed.

Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.

Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.

Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.


Mon - Fri, 8:30 AM - 5:00 PM

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