QA Auditor I

at PPD (view profile)
Location Middleton, WI
Date Posted August 22, 2019
Category BioPharma
Job Type Full-time
Address 8551 Research Way, Suite 90

Description

PPD Laboratories -- Between Spark and Innovation – HERE WE ARE

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offer the most comprehensive set of laboratory services available in the industry. Our services accelerate pharmaceutical development for small molecules, biologics, and vaccines, allowing our clients to make faster decisions about their compounds.

Assures the quality of lab data and reports. Conducts internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies and addresses non-

conformance issues. Assists in the delivery of quality services for contracted quality assurance audits, internal site audits, laboratory audits and file audits for clients and projects. Applies company policies and procedures to resolve routine issues.

Responsibilities:

•Audits laboratory data for compliance with methods and standard operating procedures and report findings
•Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings

•Serves as a resource to operational departments on audit or quality assurance subject matter
•Assists in the preparation of audit findings and/or other related information
Education and Experience:

•Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree •Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

• Familiar with applicable GMP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
• Thorough working knowledge of SOPs and WPDs

• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Able to work independently or in a team environment

• Good problem-solving abilities
• Good organizational and time management skills
•Basic computer skills and ability to learn and become proficient with appropriate software
•Proven flexibility and adaptability

•Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

PPD is an affirmative action employer that values diversity as a strength, and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.

For more information, please visit www.ppdi.com/careers.

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