Deviations/CAPA Process Lead

4 days ago

Greenville, United States PAI Holdings LLC Full time
Job DescriptionJob Description


Job Title: Deviations/CAPA Team Lead Department: Quality Systems

Reports To: Deviations & Compliance Manager Status: Full Time/Exempt

JOB SUMMARY:

This position supports the Deviations & Compliance Manager in daily activities and prioritizing duties for the Deviations team. In addition, participates in investigating deviations that arise in various aspects of the company, including Manufacturing, Quality Control and Facilities, using problem solving tools such as root cause analysis to assist with identification of appropriate corrective actions to prevent recurrence. Collaborates with various departments to gather information, evaluate causal factors, and implement appropriate CAPAs, based on root causes identified in deviation. Ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to deviation investigations, deviation initiation, and related CAPA’s. Facilitates cross functional meetings and provides guidance and consultation to the deviation/CAPA process owners and makes recommendations to continuously improve processes.

The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Thoroughly investigate deviations that are initiated in the Track Wise system including, but not limited to, the following activities:
    1. Own and author deviation investigations in a concise and accurate manner, including cross-checking content for accuracy and ensuring information is clear and understandable to a broad audience.
    2. Review and assess newly initiated deviations to ensure information entered is complete and accurate and that appropriate immediate actions have been taken and documented. Ensure all potentially impacted products or material is identified in the deviation and placed on hold, when applicable.
    3. Perform initial quality impact assessments of new deviations and classify based on potential risk to patient health, safety, product quality and/or regulatory compliance.
    4. Ensure any needed interim control measures have been identified and taken to prevent continuation of deviant condition.
    5. Collaborate with Subject Matter Experts (SMEs) to ensure adherence to due dates for closure of deviations. Work with SMEs to ensure Extension Requests are initiated, when applicable, to avoid closing a deviation past the assigned due date.
    6. Review and approve completed investigation reports. Ensure completed investigations are thorough, accurate and root cause has been clearly identified and supported. Ensure all supporting documentation is attached to the deviation.
    7. Ensure any needed CAPAs are initiated and that they align with the identified root causes of the deviation.
    8. Perform Final Assessments of completed investigations. Ensure disposition of impacted product has been determined and documented, based on investigation conclusion, and associated corrective actions.
  1. Use a root cause analysis approach to evaluate and determine any discrepancy related to personnel, material, equipment, procedure, process, and environmental factors involved or related to the deviation.
  2. Gather and attach all supporting evidence during the investigation to include copies of all related documentation and/or data that supports the findings. Also collect photographs, perform personnel interviews, as needed, and view applicable video footage. Ensure that supporting documents are organized, appropriately identified, and that scanned copies are legible.
  3. Enter the investigation results in the Track Wise system. Present the investigation report in a clear, concise, and comprehensive manner. Ensure the report is also presented in a logical and sequential order that is easily followed by the target audience/reader and that the root cause has been clearly identified and supported.
  4. Identify quality trends through investigations and communicate to management.
  5. Mentor team members to conduct comprehensive investigations to determine root cause, product impact and implement corrective and preventive actions.
  6. Collaborate with Operations to develop Deviation and CAPA training curriculum for development of operations personnel.
  7. Assists with metrics and reports related to the quality system. Provides suggestive mediation of identified gaps and metrics
  8. Experience in the preparation, approval and tracking and trending of deviations, project investigations, and CAPA.
  9. Ability to streamline and coordinate local quality processes.
  10. Identifies and implements improvements to quality processes
  11. Drive continuous improvement throughout Quality Systems.
  12. Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization
  13. Ability to learn and operate various enterprise systems including TrackWise, BMS, SAP.

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree in a relevant field such as Life Sciences, Chemistry, or Engineering preferred. In lieu of science based degree, a combination of Bachelor’s degree and 10 years’ pharmaceutical experience will be considered. Advanced certifications (e.g. Root Cause Analysis, CQA) are a plus.

Minimum of 8-10 years of experience in Quality Assurance within the pharmaceutical industry. Deviation/CAPA management experience preferred.

7+ years of experience in a manufacturing/packaging cGMP environment.

Previous experience performing quality related activities within a manufacturing environment, pharmaceutical manufacturing preferred

Previous experience working within strict regulatory guidelines, cGMP or FDA preferred

KNOWLEDGE, SKILLS & ABILITIES:

  • Strong oral communication skills, ability to communicate complex and technical information in written reports in a clear, concise, logical, and sequential manner
  • Strong analytical and problem-solving skills
  • Attentiveness to details and deadlines with the ability to prioritize work effectively
  • Sound understanding of cGMPs and FDA regulations
  • Flexibility to operate, and self-driven to excel, in a fast-paced environment
  • Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven ability to shift thought processes quickly from one task to another.
  • Proficiency with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.)

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands.

PAI is an Equal Opportunity Employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled.


  • Analytical R&D Scientist II

    4 months ago

    Greenville, United States Thermo Fisher Scientific Full time

    and Requirements: Validate test methods for pharmaceutical raw materials and finished products by using analytical techniques such as HPLC, GC, LC/MS, dissolution, spectroscopy, and compendial testing. Recognize and report out-of-specification or unexpected results, contributing to problem-solving and troubleshooting efforts. Write deviations, OOS,...

  • Senior Analytical Research Scientist

    1 month ago

    Greenville, South Carolina, United States Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly skilled Analytical R&D Scientist II to join our team at Thermo Fisher Scientific. As a key member of our analytical research team, you will be responsible for developing and validating analytical methods for pharmaceutical raw materials and finished products.Key ResponsibilitiesDevelop and validate analytical methods for...

  • IT Application Specialist for Before-Cure Process

    4 weeks ago

    Greenville, South Carolina, United States Michelin Full time

    Before-Cure IT Application Specialist Job DescriptionMICHELIN is a leading mobility company that works with tires, around tires, and beyond tires to enable Motion for Life. As part of our team, you will oversee the deployment and technical support for the before-cure process-related information systems in the Americas zone.Key Responsibilities:Conduct...

  • IT Application Specialist for Before-Cure Process

    4 weeks ago

    Greenville, South Carolina, United States Michelin Full time

    Role SummaryAs an IT Application Specialist for the Before-Cure Process, you will be responsible for overseeing the deployment and technical support for related information systems in the Americas zone. This role requires collaboration with the central team in France and industrial sites to manage the deployment of preparation-related applications in...

  • Process Engineer Lead

    2 months ago

    Greenville, United States Solvenow Inc. Full time

    Process Engineer Lead will be responsible for building, leading and managing an integral group of engineering professionals in support of various projects. As part of a multi-discipline team, your team will be responsible for process design and management in support of Water Services Group projects company-wide.  Diversity in high-volume, custom plant...

  • Lead Process Engineer

    2 weeks ago

    greenville, United States LHH Full time

    Responsibilities:Develop and design process systems, ranging from simple to complex.Create and deliver process design documents, including hydraulic calculations, heat and material balances, PFDs, P&IDs, process instrumentation selection, piping materials selection, process equipment selection, process safety studies, and relief device evaluations.Provide...

  • Lead Process Engineer

    3 weeks ago

    greenville, United States LHH Full time

    Responsibilities:Develop and design process systems, ranging from simple to complex.Create and deliver process design documents, including hydraulic calculations, heat and material balances, PFDs, P&IDs, process instrumentation selection, piping materials selection, process equipment selection, process safety studies, and relief device evaluations.Provide...

  • Lead Process Engineer

    3 weeks ago

    Greenville, United States LHH Full time

    Responsibilities:Develop and design process systems, ranging from simple to complex.Create and deliver process design documents, including hydraulic calculations, heat and material balances, PFDs, P&IDs, process instrumentation selection, piping materials selection, process equipment selection, process safety studies, and relief device evaluations.Provide...

  • Lead Manufacturing Engineer

    4 weeks ago

    Greenville, South Carolina, United States GE Vernova Full time

    Job Description SummaryAre you passionate about innovation and electrifying the world? Do you have a strong background in manufacturing process development and equipment specification?We operate with a founder's mindset, delivering innovation with passion, speed, and courage. We continuously challenge our thinking and empower our team members to dream big...

  • Quality Engineer

    1 month ago

    Greenville, United States SSi People Full time

    Duties:Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide...

  • Quality Engineer

    1 month ago

    greenville, United States SSi People Full time

    Duties:Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide...

  • Method Development Chemist

    3 weeks ago

    Greenville, United States Actalent Full time

    Job DescriptionJob DescriptionOur client is seeking a method development chemist to assist with day to day operations. Description:The Method Development Chemist in the Quality Department communicates issues and progress to management regarding formulations, materials, and processes. They are responsible for onboarding new formulations, including mixing and...

  • Process Engineer

    6 months ago

    Greenville, United States Yates Construction Full time

    Position: Paper Process Engineer Location: Greenville, SC Yates is proud to be an industry leader in construction and engineering services. To be a top of class organization, Yates is dedicated to hiring individuals who understand the importance of safety; instills integrity in all aspects of their lives; are passionate about what they do; and...

  • Automation Specialist

    4 weeks ago

    Greenville, South Carolina, United States HTi LLC Full time

    HTI is seeking a skilled professional to lead the development and implementation of automated packaging systems for pharmaceutical products. As an Automation Packaging Engineer, you will be responsible for designing and developing automated systems, troubleshooting process and equipment issues, and leading cross-functional teams to improve OEE, reduce costs,...

  • Quality Assurance Engineer III

    1 month ago

    greenville, United States Planet Pharma Full time

    Required Skills:CAPAEQUIPMENT VALIDATIONISOGMPAdditional:SIX SIGMADuties:Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety,...

  • Process Engineer

    4 weeks ago

    Greenville, United States Berry Global Inc Full time

    Overview About Berry At Berry Global Group, Inc. (NYSE: BERY), we create innovative packaging and engineered products that we believe make life better for people and the planet. We do this every day by leveraging our unmatched global capabilities, sustainability leadership, and deep innovation expertise to serve customers of all sizes around the...

  • Quality Assurance Engineer III

    1 month ago

    Greenville, United States Planet Pharma Full time

    Required Skills:CAPAEQUIPMENT VALIDATIONISOGMPAdditional:SIX SIGMADuties:Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety,...

  • Process Engineer

    6 months ago

    Greenville, United States BASF SE Full time

    Now Hiring! Process Engineer   Greenville, OH    The world needs creative solutions. We need YOU!   Where the chemistry happens… In this role, you will be responsible for supporting the day-to-day operation and technical support needed to execute the required production plan for Acrylics production. You will also demonstrate strong leadership in...

  • Sr Manufacturing Quality Engineer

    2 weeks ago

    Greenville, United States Polara Enterprises Full time

    Job Type Full-timeDescriptionPosition Title: Sr Manufacturing Quality EngineerSalary Classification: ExemptReports to: QA ManagerSupervises: NASummary:Under the minimal supervision of the Quality Manager. Provides technical support for the development and implementation of ISO 9000 Quality Management systems in a Lean Continuous Process Improvement...

  • Process Engineer

    6 months ago

    Greenville, United States BASF SE Full time

    Now Hiring! Process Engineer   Greenville, OH   The world needs creative solutions. We need YOU!   Where the chemistry happens… In this role, you will be responsible for supporting the day-to-day operation and technical support needed to execute the required production plan for ECoat Paste production. You will also demonstrate strong leadership in...