6541 - Lab Technician / Validation Engineer

United States·Indianapolis

QA & TestingValidation Engineer

0 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Develop and maintain knowledge of applicable regulations and

Technical Tools

QA & TestingValidation Engineer

Description

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

Responsibilities

~2 min read

→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

~1 min read

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.

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.

*Verista is an equal opportunity employer.

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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com