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Lead Deviation Investigator

  • ... Verista
  • ... Baltimore, Maryland,
  • ...

    Contract

  • ... Salary: 129826 per year
  • Posted on: Aug 12, 2024

Lead Deviation Investigator   

JOB TITLE:

Lead Deviation Investigator

JOB TYPE:

Contract

JOB LOCATION:

Baltimore Maryland United States

REMOTE:

No

JOB DESCRIPTION:

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Lead Deviation Investigator Responsibilities:

Oversee a team of Deviation Investigators. Your team's responsibilities include:

  • Quality Record Initiation: Initiate quality records promptly and accurately for identified deviations, ensuring alignment with both industry and Client expectations.
  • Deviation Investigations: Conduct thorough investigations for identified deviations, employing root cause analysis methodologies.
  • Assess the impact on product quality with input from various departments.
  • CAPA Identification and Implementation: Identify and recommend Corrective and Preventive Actions (CAPA) based on investigation findings.
  • Collaborate with stakeholders to ensure the effective implementation of CAPA measures.
  • Comments Resolution: Timely resolution of internal and client comments related to investigations.
  • Collaborate with relevant parties to address and close out comments effectively.
  • Document Retrieval and Operator Interviews: Retrieve necessary supporting documents to substantiate investigation findings.
  • Conduct interviews with manufacturing operators to gather relevant information.

Requirements

Weekend Availability: Be available to work on weekends as required, addressing urgent deviations and supporting continuous improvement efforts.

Performance Metrics:

  • Timely initiation and completion of quality records.
  • Thoroughness and accuracy in deviation investigations.
  • Meeting the minimum requirement of closing 2-3 deviations per week.
  • Effectiveness in identifying and implementing CAPA measures.
  • Availability and responsiveness during weekends.
  • Efficient resolution of internal and client comments.
  • Competency in retrieving supporting documents and conducting interviews.

Reporting:

  • Regular status reports will be provided by Investigators to relevant stakeholders. These reports will include updates on ongoing investigations, status of CAPA implementation, and any issues or challenges encountered during the process.

Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

For more information about our company, please visit us at 

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

$85,000-129,826

*Verista is an equal opportunity employer.

Position Details

POSTED:

Aug 12, 2024

EMPLOYMENT:

Contract

SALARY:

129826 per year

SNAPRECRUIT ID:

SD-57ec8d8ae5d8dbcd331ab7fd2fba0a47892599ad067568968c3975e2530f9f68

CITY:

Baltimore

Job Origin:

WORKABLE_ORGANIC_FEED

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Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Lead Deviation Investigator Responsibilities:

Oversee a team of Deviation Investigators. Your team's responsibilities include:

  • Quality Record Initiation: Initiate quality records promptly and accurately for identified deviations, ensuring alignment with both industry and Client expectations.
  • Deviation Investigations: Conduct thorough investigations for identified deviations, employing root cause analysis methodologies.
  • Assess the impact on product quality with input from various departments.
  • CAPA Identification and Implementation: Identify and recommend Corrective and Preventive Actions (CAPA) based on investigation findings.
  • Collaborate with stakeholders to ensure the effective implementation of CAPA measures.
  • Comments Resolution: Timely resolution of internal and client comments related to investigations.
  • Collaborate with relevant parties to address and close out comments effectively.
  • Document Retrieval and Operator Interviews: Retrieve necessary supporting documents to substantiate investigation findings.
  • Conduct interviews with manufacturing operators to gather relevant information.

Requirements

Weekend Availability: Be available to work on weekends as required, addressing urgent deviations and supporting continuous improvement efforts.

Performance Metrics:

  • Timely initiation and completion of quality records.
  • Thoroughness and accuracy in deviation investigations.
  • Meeting the minimum requirement of closing 2-3 deviations per week.
  • Effectiveness in identifying and implementing CAPA measures.
  • Availability and responsiveness during weekends.
  • Efficient resolution of internal and client comments.
  • Competency in retrieving supporting documents and conducting interviews.

Reporting:

  • Regular status reports will be provided by Investigators to relevant stakeholders. These reports will include updates on ongoing investigations, status of CAPA implementation, and any issues or challenges encountered during the process.

Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

For more information about our company, please visit us at 

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

$85,000-129,826

*Verista is an equal opportunity employer.

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