QC Data Reviewer - Bristol PA

Job Description

Job Description

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 request

Requirements:

• 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 to Have:

• Working knowledge of HPLC, 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 standards

Working 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 View email address on ziprecruiter.com or call View phone number on ziprecruiter.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. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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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