Job Information
Randstad US quality control specialist (gmp) in philadelphia, Pennsylvania
quality control specialist (gmp).
philadelphia , pennsylvania
posted july 9, 2024
job details
summary
$38 - $40 per hour
contract
bachelor degree
category life, physical, and social science occupations
reference48431
job details
job summary:
The Quality Control Specialist will be responsible for the following:
Perform daily GMP Quality Control laboratory testing activities
Perform data analysis and result reporting to support product lot release with adherence to turnaround times.
Support method transfers and method validation testing
Support generation and revision of documentation, such as SOPs, protocols and reports, deviations, laboratory investigations, CAPAs and change controls.
Support technical problem solving for issues pertaining to GMP QC activities
Support product stability programs including execution of stability testing and stability data analysis
Perform peer review and or technical review of laboratory data and logbook
Responsible for reagent inventory and equipment cleaning and maintenance
location: Philadelphia, Pennsylvania
job type: Contract
salary: $38 - 40 per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
Execution of In-process, finished product, and stability samples (60%)
Support method qualifications, technology transfer and method validations (10%)
Author/Revise SOP's and Test Methods, Deviations, CAPA's and Change Controls (20%)
Responsible for inventory and instrument/equipment maintenance (10%)
qualifications:
Bachelor's degree in molecular biology, biomedical sciences or related specialties
Minimum of 2 years experience in the pharmaceutical industry working in a GMP quality control laboratory
Experience with cell culture, aseptic technique, cell-based potency assays, and flow cytometry
Proficient knowledge of GMP regulations including USP and EP testing requirements
Intermediate experience conducting time critical testing of in-process and finished product to meet in process manufacturing needs
Ability to author, review and maintain test methods, qualification protocols, SOPs and reports
Conduct laboratory investigations, complete deviations, CAPAs and change controls as needed
Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
Technical writing skills for drafting equipment and laboratory standard operating procedures
Ability to follow instructions provided by SOP's and to document results clearly and in a timely manner following performance of tasks
Ability to work as a member of team where combined contribution, collaboration, and time bound results are expected.
Preferred:
3+ years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus
Ability to identify and implement continuous improvement projects for lab process efficiencies
Ability to identify and escalate defects for troubleshooting and solution.
Ability to work on assigned projects independently with limited supervision.
Communicate effectively with team members and the ability to work cross functionally
skills: Quality control, Flow Cytometry, Cell Cultures, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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