Deviation Investigator

2 months ago

Lansdale, United States Insight Global Full time

One of our large pharmaceutical clients is actively seeking a Deviation Investigator to join the specialty products & services and incoming materials team located in Lansdale, PA. They will be responsible for ensuring that deviations are thoroughly investigated, risks are managed, and corrective actions are taken to maintain equipment quality & compliance in the pharmaceutical industry. This person needs to have experience authoring investigations & incidents for pharmaceutical raw materials. Their main responsibility is coordinating QNs (Quality Notifications), identify point of occurrence, investigate root cause, and evaluate product impact by using DM tools to close incidents and investigations by assigned due date. This role is a year long contract with potential for extensions and has a hybrid schedule of 3 days onsite & 2 days WFH. Other responsibilities include:

  • Authors incident and investigation reports for deviations
  • Coordinates and completes Corrective Actions and Preventive Actions (CAPAs)
  • Authors and reviews Incident Trend Reports and support deviation reduction efforts
  • Supports, executes, and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
  • Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
  • Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment.
  • Provides on-the-floor support for project implementation and studies, as required
  • Leads or participates in Quality Risk Assessments and supports team safety, environmental, and compliance objectives.
  • Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
  • Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors.


Qualifications:

  • Bachelor's Degree in a related field of study
  • Minimum of 2 years of deviation or change control management experience within a GMP environment
  • Prior quality and deviation investigation experience
  • Strong technical writing skills


Pay: $38.00-$47.00/hr (flexible based on experience)

Hours: Monday-Friday, 9:00am-5:00pm

Hybrid Schedule: 3 days onsite & 2 days WFH

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

Benefits: Medical, Dental, Vision and 401K plans available


Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

  • Deviation Management Specialist

    5 days ago

    Lansdale, United States Insight Global Full time

    Required Skills & ExperienceB.S. or B.A. in Engineering, Sciences, or related disciplineMinimum two (2) years post-bachelor's degree experience in a regulated environment.Experience in deviation management and/or change control and/or bio-pharm equipmentTechnical WritingHighly developed communication, leadership and teamwork skills.Nice to Have Skills &...

  • Deviation Management Specialist

    2 weeks ago

    Lansdale, United States eTeam Full time

    Deviation Management Specialist - I (Assistant)West Point, PA12 Month contractPay rate: $41.78/hr - Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory...

  • Deviation Management Specialist

    1 month ago

    Lansdale, United States Integrated Resources, Inc ( IRI ) Full time

    Top skillsets: Previous DM experience, root cause analysis experience, Time management (deadlines/deliverables), Investigation Writing experience. Responsibilities:Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of...

  • Deviation Management Specialist

    4 weeks ago

    Lansdale, United States Merck Full time

    Qualifications:•B.S./M.S. degree in appropriate engineering/scientific field •Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry •Previous experience in writing investigations for atypical events in a...

  • Investigations Specialist

    2 months ago

    Lansdale, United States eTeam Full time

    Title: Deviation Management Specialist - I (Assistant)Qualifications:- Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations- This individual...

  • Investigations Specialist

    4 weeks ago

    Lansdale, United States eTeam Full time

    - Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations- This individual will be responsible for providing scientific support for...

  • Manufacturing Investigator

    1 week ago

    Lansdale, Pennsylvania, United States eTeam Full time

    **Company Overview:**eTeam, a leading company in the manufacturing industry, is seeking a highly skilled Manufacturing Investigator to join our team.The ideal candidate will have a strong background in technical support, with experience in investigating process deviations and developing corrective/preventative actions. As a Manufacturing Investigator, you...

  • Manufacturing Investigator

    7 days ago

    Lansdale, Pennsylvania, United States eTeam Full time

    About the RoleThis Manufacturing Investigator position is an excellent opportunity to work in a dynamic and fast-paced environment where you will utilize your technical expertise to drive process improvements and ensure compliance with regulatory requirements.As a key member of our eTeam, you will be responsible for investigating process deviations,...

  • Quality Assurance Specialist

    2 months ago

    Lansdale, United States eTeam Full time

    Deviation Management Specialist - I (Assistant)West Point, PA12 Months contractPay $41.78/hr• Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.• Has...

  • Process Development Engineer

    7 days ago

    Lansdale, Pennsylvania, United States eTeam Full time

    Job DescriptionWe are seeking a Process Development Engineer to join our eTeam in a critical role that requires technical expertise and strong analytical skills. The successful candidate will be responsible for providing technical support to manufacturing operations, identifying and resolving process deviations, developing and implementing corrective...

  • Senior Quality Assurance Specialist

    1 week ago

    Lansdale, Pennsylvania, United States eTeam Full time

    Job Title: Senior Quality Assurance Specialist - Manufacturing OperationsAbout the Role:eTeam is seeking a highly skilled Senior Quality Assurance Specialist - Manufacturing Operations to join our team. In this role, you will be responsible for providing day-to-day technical support to manufacturing operations, including resolution and reduction of process...