qc biochemistry analyst.

• pennington , new jersey

• posted july 10, 2024

job details

summary

• $43.97 - $51.72 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference48448

job details

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Pennington, New Jersey

job type: Contract

salary: $43.97 - 51.72 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

Job Summary

Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures.

Essential Functions of the job:

• Perform QC biochemistry assay validation and transfer activities, including testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.

• Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.

• Manage inventory of reagents and supplies for the laboratory.

• Lead investigations of OOS, discrepancies, errors, failures requiring documented review and action.

• Participate in internal and external GMP audits where possible.

• Lead method transfer and method validation activities, prepare protocols and reports.

• Train other junior level analysts and new hires.

• Subject matter expert in one or more areas of required testing.

• Undertake any other duties as required.

qualifications:

Core Competencies, Knowledge, and Skill Requirements

• Working experience in an FDA-regulated biotechnology, pharmaceutical company are required.

• Serve as subject matter expert for residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis(cIEF), including qualification, assay validation and transfer activities.

• Working knowledge with USP/EP and cGMP/EU GMP.

• Familiar with instrument and equipment validation.

• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

• Strong leadership/team management skills and experience.

• Credible and confident communicator (written and verbal) at all levels.

• Strong analytical and problem-solving ability.

• Hands-on approach, with a 'can do' attitude.

• Ability to prioritize, demonstrating good time management skills.

• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

• Self-motivated, with the ability to work proactively using own initiative.

• Committed to learning and development.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Travel:

• Must be willing to travel approximately 10%

• Ability to work on a computer for extended periods of time

Education Required:

Minimum of 2+ years with a bachelor's or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline. 5+ years of experience preferred.

skills: PCR, Biology, 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.