QC Data Reviewer - Bristol PAKelly® Science & Clinical is seeking a QC Data Reviewer 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 experienceOverview: 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 dataCollaborate with QC team members and cross-functional teams to resolve quality issues and achieve project goalsSupport product release activities, ensuring timelines are metAnalyze data to evaluate factors of diverse scope; resolve issues with assistance from the Data Review teamReview LIRs (Lab Investigation Reports)Support all data integrity initiatives and strive for right first timeMake daily decisions about quality of data based on biochemical knowledge and compliance backgroundRevise, create SOPs and/or test forms as requiredAssist with metrics for trending and reporting as required, covering stability and QC analytical dataProvide timely status updates to Management upon requestRequirements:B.S.
in Chemistry, Biology, Chemical Engineering, or related biological sciences5+ years in a cGMP analytical laboratory environment, including 3+ years in Quality data analysis/review experience– open to various industries, pharmaceutical strongly preferredTask and team-oriented, analytical, organized, detail-oriented, self-motivated, and ability to multitaskExceptional communication and interpersonal skillsStrong knowledge of QC analytical equipment and software requiredProficient with MS Outlook, Word, Excel, PowerPoint, and other electronic systemsStrong written and verbal communication skillsAble to prioritize workload to meet stringent timelinesPreferred/Nice to Have:Working knowledge of HPLC, UPLC, LC-MSExperience with EMPOWER software – strongly preferredExperience 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 requirementsWill interact with other departmentsPace may be fast and job completion demands may be highMay be required to stand for long periods while reviewing lab logbooks, equipment, and documentationMust be able to walk distances between labs, offices, departmentsMust be able to work safely in a lab environmentPPE as requiredFor more information or to be considered, send resumes to
QC Data Reviewer - Bristol PA in bristol at Unknown Company
This position is listed as contract and onsite.