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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.