Deviation Specialist

4 weeks ago

Greenville, South Carolina, United States PAI Holdings LLC Full time
Job Description

Job Summary:

This position is responsible for investigating deviations that occur in various aspects of the company, including manufacturing, quality control, and facilities. The Deviation Specialist will use problem-solving tools such as root cause analysis to identify appropriate corrective actions to prevent recurrence. They will collaborate with various departments to gather information, evaluate causal factors, and implement appropriate CAPAs based on root causes identified in deviation.

The Deviation Specialist will ensure quality and compliance to cGMPs, internal, external, and international requirements with respect to deviation investigations, deviation initiation, and related CAPAs. They will facilitate cross-functional meetings and provide guidance and consultation to the deviation/CAPA process owners and make recommendations to continuously improve processes.

The ideal candidate will be a detail-oriented, highly organized, and self-motivated individual who is responsible for coordinating investigative activities and writing concise and accurate deviation investigation reports. Additionally, this position will track, trend, and analyze investigation data to identify potential trends and report this information to management/leadership.

Key Responsibilities:

  1. Investigate deviations that are initiated in the Track Wise system, including thorough analysis of the deviation and identification of root causes.
  2. 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.
  3. Review and assess newly initiated deviations to ensure information entered is complete and accurate and that appropriate immediate actions have been taken and documented.
  4. Perform initial quality impact assessments of new deviations and classify based on potential risk to patient health, safety, product quality, and/or regulatory compliance.
  5. Ensure any needed interim control measures have been identified and taken to prevent continuation of deviant condition.
  6. 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.
  7. 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.
  8. Ensure any needed CAPAs are initiated and that they align with the identified root causes of the deviation.
  9. Perform Final Assessments of completed investigations. Ensure disposition of impacted product has been determined and documented, based on investigation conclusion, and associated corrective actions.
  10. 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.
  11. 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.
  12. 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.
  13. Identify quality trends through investigations and communicate to management.

Requirements:

  • Bachelor's degree preferred but will consider associate degree, or equivalent mix of education and experience, preferably in the pharmaceutical industry.
  • 2+ years of experience in a manufacturing/packaging cGMP environment.
  • 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.

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

  • Mail Production Specialist

    4 weeks ago

    Greenville, South Carolina, United States Amsive Full time

    Job SummaryAmsive is seeking a skilled Mail Production Specialist to join our team. As a key member of our lettershop, you will be responsible for the production and mailing of direct mail campaigns. Your attention to detail and ability to work efficiently in a fast-paced environment will be essential in ensuring the success of our mailings.Key...

  • Chemical Production Specialist

    3 weeks ago

    Greenville, South Carolina, United States PrideStaff Full time

    PrideStaff Job Description:As a Chemical Operator at PrideStaff, you will be responsible for operating machinery to mix chemicals for production. You will also monitor and adjust equipment to maintain quality standards, conduct routine maintenance and troubleshooting on chemical processing machinery, and ensure compliance with safety regulations and...

  • Quality Assurance Specialist III

    4 weeks ago

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

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist III to join our team at Thermo Fisher Scientific. In this role, you will be responsible for driving quality execution across sterile operations, including manufacturing, filling, packaging, and inspection. You will also provide quality guidance and expertise for the implementation of...

  • IT Application Specialist for Before-Cure Process

    3 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...

  • IT Application Specialist for Before-Cure Process

    3 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...

  • Mail Production Specialist

    4 weeks ago

    Greenville, South Carolina, United States Amsive Full time

    Job SummaryAs a Mail Production Specialist at Amsive, you will play a vital role in the production and mailing of direct mail campaigns. Your responsibilities will include printing, folding, inserting, addressing, and sorting letters, postcards, brochures, or other marketing materials. You will ensure that the direct mail pieces are accurately assembled and...

  • Automation Specialist

    3 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,...

  • IT Application Specialist

    4 weeks ago

    Greenville, South Carolina, United States Michelin Full time

    Job Summary:As an IT Application Specialist for Preparation Process, you will oversee the deployment and technical support for preparation process-related information systems in the Americas zone. You will work closely with the industrial sites and the central team in France to manage the deployment of preparation-related applications in American plants...

  • IT Application Specialist for Americas Zone

    4 weeks ago

    Greenville, South Carolina, United States Michelin Full time

    About the Role:The IT Application Specialist for the Americas Zone will oversee the deployment and technical support for the before-cure process related information systems in the Americas zone. This role will work closely with the industrial sites and the central team in France to manage the deployment of preparation-related applications in the American...

  • Mechanical Design Engineer

    4 weeks ago

    Greenville, South Carolina, United States Insight Global Full time

    Job Summary:Insight Global is seeking a highly skilled Mechanical Design Engineer to join their Turbine Module Design Liaison Engineering team. The ideal candidate will have a strong background in mechanical engineering, with a focus on design and project management.Key Responsibilities:Technical focal for compressor airfoils, including qualifications,...

  • Dental Care Specialist

    1 month ago

    Greenville, South Carolina, United States Wellpath Full time

    Job SummaryThe Dentist will provide dental services to inmate patients, adhere to the security regulations of the assigned institution, and document services to monitor compensation for service compliance with client contracts.ResponsibilitiesExamine, supervise, and provide dental care/treatment to referred patientsUtilize standard precautions when providing...

  • Cardiovascular Imaging Specialist

    4 weeks ago

    Greenville, South Carolina, United States Bon Secours Mercy Health Full time

    Job SummaryThe Special Procedures and Cath Lab Technologist will assist the Licensed Practitioner in the completion of fluoroscopic and specialized interventional and Neuro-Interventional procedures while using sterile technique. They prepare, administer and document activities related to medications and radiation exposure in accordance with federal and...

  • Radiation Therapist

    4 weeks ago

    Greenville, South Carolina, United States Prisma Health Full time

    About the RoleWe are seeking a skilled Radiation Therapist to join our team at Prisma Health. As a Radiation Therapist, you will play a critical role in delivering high-quality patient care and contributing to the success of our cancer treatment program.Key ResponsibilitiesInterpret and deliver prescribed courses of radiation therapy, preparing treatment...

  • Interventional Radiology Technologist

    4 weeks ago

    Greenville, South Carolina, United States Bon Secours Mercy Health Full time

    About the Role:The Special Procedures and Cath Lab Technologist will assist the Licensed Practitioner in the completion of fluoroscopic and specialized interventional and Neuro-Interventional procedures while using sterile technique.Key Responsibilities:Performs high quality diagnostic vascular laboratory examinations using ultrasound and physiologic testing...

  • Biopharmaceutical Commissioning Engineer

    4 weeks ago

    Greenville, North Carolina, United States MMR Consulting Full time

    About MMR ConsultingMMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Engineering, Project Management, and other Consulting services. We have expertise in Process, Automation, Facilities engineering, and Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids,...

  • Loan Specialist

    2 weeks ago

    Greenville, United States BankTalent HQ Full time

    ESSENTIAL RESPONSIBILITIESPerforms a quality check of all loans boarded with escrow services validating the escrow payees, deposits collected at closing, and payment schedules.Tracks and verifies all portfolio loans with escrow servicing, staying apprised of the latest escrow regulations while working closely with the Bank‘s Loan Compliance Team.Runs...

  • Preparation IT Application Specialist

    4 weeks ago

    Greenville, United States Michelin Full time

    Preparation IT Application Specialist Michelin is hiring! - - - - - - - - - - - - US0 Central Engineering Headquarters: Come join our growing team of mechanical, electrical, automation, and IT engineers at our Central Engineering headquarters, located at the Donaldson Campus in Greenville, South Carolina. Our team of Engineers is responsible for the...

  • Before-Cure IT Application Specialist

    4 weeks ago

    Greenville, United States Michelin Full time

    Before-Cure IT Application Specialist Michelin is hiring! - - - - - - - - - - - - US0 Central Engineering Headquarters: Come join our growing team of mechanical, electrical, automation, and IT engineers at our Central Engineering headquarters, located at the Donaldson Campus in Greenville, South Carolina. Our team of Engineers is responsible for the...

  • Biopharmaceutical COMMISSIONING

    2 weeks ago

    Greenville, United States MMR Consulting Full time

    Previous Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering....

  • Biopharmaceutical COMMISSIONING

    2 weeks ago

    greenville, United States MMR Consulting Full time

    Previous Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering....

  • Biopharmaceutical COMMISSIONING

    2 weeks ago

    greenville, United States MMR Consulting Full time

    Previous Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering....

  • Biopharmaceutical COMMISSIONING

    2 weeks ago

    Greenville, NC, United States MMR Consulting Full time

    Previous Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering....