Senior QA Auditor Job Listing at Kelly Services in Scott Township, PA (Job ID 9680100)

Description

Kelly® Science & Clinical is seeking a Senior QA Auditor for a direct hire, permanent position at cutting-edge clinical research and biopharmaceutical client in Scott Township, PA.  If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.


Location: Hybrid in Scott Township, PA > 3-4 days/week onsite, 1-2 days/week WFH
Compensation: $100k-125k/yr
Schedule:  1st shift, M-F
                                                                                                      
SUMMARY
The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements. The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. The Senior QA Auditor is responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.

RESPONSIBILITIES

• Audits phases of nonclinical and laboratory studies, reports, and performs related duties (e.g., issues audits and QA statements) to ensure regulatory compliance.
• Audits all disciplines (examples of disciplines include Method Validations, Non- Clinical GLP Studies).
• Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
• Performs facility audits to ensure that the facility is in compliance with regulations.
• Acts as lead auditor on studies and projects.
• Maintains computerized files to support audit activities.
• Supports project planning and implementation.
• Provides risk-based compliance opinions and guidance.
• Writes and issues inspection reports.
• Works with internal clients to ensure that inspection findings are clearly communicated and understood.
• Evaluates inspection finding responses to ensure they are written to address the findings appropriately.
• Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
• Identifies and communicates opportunities for process improvements based on audit and inspection observations.
• Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multi-departmental interactions.
• Maintains necessary documentation of QA records and study files.
• Notifies management of observed quality and compliance trends in the areas inspected.
• Autonomously performs SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
• Under supervision of a mentor/coach, performs the following tasks: interpretation of FDA, regulations; project management; regulatory guidance review; quality issue investigations; and QA data collection, trending and analysis.
• Recommends modifications in procedures to fit special needs or problems and involve manager when assistance in process improvement/resolution is necessary.
• Interprets and can train on GLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
• Carries out appropriate self-development efforts as directed.
• Assists with regulatory training of staff.

QUALIFICATIONS

• Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
• Two to three years related technical experience and/or training.
• A minimum of two years auditing in a GLP-regulated environment.
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality– Certified Quality Auditor) or other certification is recommended.
• Microsoft Office Suite
• Training needs for this position include on-the-job training in performing audits and inspections, and independent reading of professional articles, journals and internal SOPs.
• Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.
• P#1

Benefits Package Includes • Health/Dental/Vision Insurance Plans • 401(k)/RRSP with Employer Match • Paid Vacation and Holidays • Paid Sick and Bereavement Leave • Employee Assistance & Telehealth Programs
Incentive Programs Include • Training & Development Programs • Employee Referral Bonus Program • Annual Performance Reviews

Send resumes to Jacqueline.Sayoc@KellyScientific.com

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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