Indiana Disability Jobs

Job Overview:

Quality Assurance (QA) Manager - Bioanalysis

We are offering a sign-on bonus of $5,000 ($2,500 upon hire and another $2,500 after 6 months)

Are you an experienced Immunochemistry (iChem) and/or LCMS scientist? Do you have previous management experience? If so, we want you to join our Global QA team as the Quality Assurance (QA) Manager, Bioanalysis in Indianapolis, IN.

Covance by Labcorp’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

Position Overview

• Working knowledge of LC/MS bioanalysis, FDA Guidance for Industry: Bioanalytical Method Validation

• Manages QA group responsible for auditing Method Validation, GLP regulated and GCP regulated bioanalysis

• Interpret applicable quality regulations/standards and create appropriate policies and procedures

• Lead and manage interactions with clients and regulatory agencies

• Recruit, train, coach and develop individuals based on their development or business needs

• Consideration would be given to a scientist with commensurate experience

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Education/Qualifications:

• A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)

• Experience may be substituted for education

Experience:

• 8 years’ in regulatory environment (experience in GLP/GCP roles preferred)

• Experience & regulatory expertise of industry quality systems/standards

• Ability to interpret applicable regulations/standards

• Experience in leading process improvement initiatives

• Ability to communicate and negotiate internal stakeholders effectively

• Ability to supervise resources in a single geographic location

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.