Verista

6541 - Lab Technician / Validation Engineer

Verista • $69K — $95K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 3-5 years of experience in a regulated industry with knowledge of quality systems and regulatory requirements (cGMP, ISO 13485, etc.)
  • Strong problem-solving and analytical skills
  • Excellent verbal and written communication skills in English
  • Self-motivated with strong teamwork abilities
  • Computer literate in Microsoft applications

Responsibilities

  • Develop and maintain understanding of relevant regulations and requirements
  • Provide Quality Control (QC) support for the laboratory
  • Implement and enhance quality systems in the QC lab
  • Author and instruct on on-the-job training for lab operations
  • Participate in new product design and pre-launch preparation for device testing

Benefits

  • High growth potential in a fast-paced, people-focused culture
  • Competitive pay with performance-based incentives
  • Company-paid life and disability insurance
  • Comprehensive medical, dental, and vision insurance
  • 401(k) with employer matching
  • Tuition reimbursement and paid social activities
  • Generous paid time off with rollover options
Full Job Description
Description

Lab Technician Responsibilities:
  • Develop and maintain knowledge of applicable regulations and requirements.
  • Provide Quality Control (QC) support for the QC laboratory.
  • Implement, maintain, and /or enhance appropriate quality systems within QC laboratory.
  • Author, maintain, and instruct on on-the-job courses for laboratory equipment, testing inspection, and laboratory operations.
  • Perform and oversee QC laboratory equipment setup, operation, and maintenance.
  • Build and maintain working relationships with multiple functions and Contract Manufacturers supporting batch release testing
  • Participate in new product design and pre-launch preparation projects to support laboratory operations and device testing.
  • Participate in departmental process improvement activities.
  • Maintain laboratory inventory management.
  • Assist in equipment qualification testing activities including IQ, OQ, and PQ.
  • Maintain and manage the reference sample retention area.
  • Support and perform laboratory device testing for commercial and development product using good documentation practices.
  • Perform test equipment setup, operation, and maintenance.
  • Support shipping and receiving activities as assigned.
  • Create /Edit lot release workshops as needed.
  • Maintain laboratory notebooks, including authoring, revision, and retirement
  • Participate in regulatory agency and internal inspections.
  • Ensure that all test equipment is properly validated and maintained for its intended use.
  • Support Event Management through roles of originator and executor of deviations impacting the QC laboratory, including origination of SARE as appropriate.
  • Support Change Management through roles of originator and /or executor of tasks and implementation steps.

Requirements:
  • Minimum of 3-5 years of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e .g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL )
  • Strong problem solving and analytical thinking skills
  • Strong verbal and written communication skills in English.
  • Self-management / motivated.
  • Demonstrated techComputer literate in Outlook, Windows and Microsoft applications
  • Excellent teamwork and abilitiy to multi-task.
  • Strong curiosity skills with the ability to question /identify issues and work to resolution.
  • Strong critical thinking /problem solving skills with an ability to apply rationale.

Additional Preferences:
  • Three years experience in Quality or TS /MS support.
  • Attention to detail.
  • Experience with Microsoft Office Suite
  • Above average computer literacy and computer skills - specific training relating to software used will be provided.
  • Demonstrated knowledge and application of federal regulations as applicable to the pharmaceutical industry and related quality systems.
  • Ability to mentor /train others - share learning.


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.

National (US) Range

$69,300-$95,358 USD

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 Verista.com

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Enterprise Technology
Founded
2017
* Ladders Estimates

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