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Kelly Services
QC Data Reviewer - Bristol PA
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Based on Pennsylvania data
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What they do
A Quality Assurance Auditor regularly evaluates the quality control systems in place and verifies compliance with quality and safety standards.
$54,865 / year median in Pennsylvania
-5% projected decline
Job Description
QC Data Reviewer - Bristol PA Apply Now Applied To save a job sign in or get started
Barbourz@kellyscientific.com or call 804-991-0745 10374748 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.
Job ID:
10374748 Posted today Back Bristol, PA, US Scientific Bachelors Degree Full Time, Temporary $40-60/hr Experienced (Non-Manager) On-site Biotechnology/Pharmaceuticals First Shift (Day) Bristol, PA, US $40-60/hr Experienced (Non-Manager) Full Time, Temporary Biotechnology/Pharmaceuticals On-site Scientific Bachelors Degree First Shift (Day) Apply Now Applied Job details Kelly® Science & Clinical is seeking a 2 QC Data Reviewers for a contract position (minimum 4 months, with potential to convert to full-time) at a premier client in Bristol, 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.Salary/Pay Rate/Compensation:
$40-$60 per hour - based on experience Overview This client is an industry-leading company focused on quality control in the life sciences sector. In this role you'll be working with QC team members and cross-functional teams to review documentation and analytical data related to routine QC tasks including Tech transfer, GMP release, and stability testing. This role will give you an opportunity to build deep compliance and technical expertise while advancing quality data review processes for the organization.Schedule:
100% on-site position; working hours will rotate every 3 weeks; for example, first 2 weeks, Mon-Fri, regular hours (5-8hrs); third week, Wed - Sat OR Sun - Wed (4-10hrs)Responsibilities:
Review and approval of cGMP analytical data comparing results to internal and customer specifications, SOPs, and established standards to ensure accuracy and quality of data Collaborate with QC team members and cross-functional teams to resolve quality issues and achieve project goals Support product release activities, ensuring timelines are met Analyze data to evaluate factors of diverse scope; resolve issues with assistance from the Data Review team Review LIRs (Lab Investigation Reports) Support all data integrity initiatives and strive for right first time Make daily decisions about quality of data based on biochemical knowledge and compliance background Revise, create SOPs and/or test forms as required Assist with metrics for trending and reporting as required, covering stability and QC analytical data Provide timely status updates to Management upon requestRequirements:
B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences 5+ years in a cGMP analytical laboratory environment, including 3+ years in Quality data analysis/review experience- open to various industries, pharmaceutical strongly preferred Task and team-oriented, analytical, organized, detail-oriented, self-motivated, and ability to multitask Exceptional communication and interpersonal skills Strong knowledge of QC analytical equipment and software required Proficient with MS Outlook, Word, Excel, PowerPoint, and other electronic systems Strong written and verbal communication skills Able to prioritize workload to meet stringent timelines Preferred/Nice toHave:
Working knowledge ofHPLC, UPLC, LC-MS
Experience with EMPOWER software - strongly preferred Experience with stability testing and strong familiarity with ICH guidelines, including but not limited to:ICH Q1A-Q1E
(Stability), ICH Q2(R2) (Analytical Method Validation), ICH Q3A/B (Impurities in Drug Substances and Products) Familiarity with analytical data trending, specification setting, and interpretation in alignment with regulatory and internal standardsWorking Conditions:
Personal protective equipment must be worn in the laboratories according to safety requirements Will interact with other departments Pace may be fast and job completion demands may be high May be required to stand for long periods while reviewing lab logbooks, equipment, and documentation Must be able to walk distances between labs, offices, departments Must be able to work safely in a lab environment PPE as required For more information or to be considered, send resumes to Tierra.Barbourz@kellyscientific.com or call 804-991-0745 10374748 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.