QC Analyst IV Chemistry and Microbiology

4 days left

Employer
Randstad
Location
Somerset County, New Jersey, US
Salary
Competitive
Posted
Jun 10, 2021
Closes
Jun 16, 2021
Ref
2167491846
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
QC Analyst IV Chemistry and Microbiology
job details:
- location:Somerset, NJ
- salary:$75,000 - $85,000 per year
- date posted:Tuesday, June 8, 2021
- experience:5 Years
- job type:Permanent
- industry:Professional, Scientific, and Technical Services
- reference:36326
job description
QC Analyst IV Chemistry and Microbiology
job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find 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: Somerset, New Jersey
job type: Permanent
salary: $75,000 - 85,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
Perform testing/review on incoming materials, in-process and finished products, and stability studies in QC Laboratory. Provide support and technical expertise to ensure quality, compliance and efficiency in QC laboratory performance.
Analytical: Utilize HPGe, HPLC, GC and other required equipment. Responsible for reserves and internal stability studies. Work with MTD and vendors on Reference Standard programs supporting commercial products.
Microbiology: Familiar with aseptic technique. Perform bioburden, sterility tests in cleanroom BSCs. Perform Environmental Monitoring using EM Total Particulate/Viable monitors, and other required equipment/materials. Coordinate growth promotion/IDs.
Job Responsibilities
- Perform routine, non-routine and more advanced lab testing in accordance with SOPs and cGMP guidelines. Perform a wide variety of methods and utilize equipment ranging from basic to complex. Perform verification and approval of data to ensure accuracy. Minimal supervision.
- May assist with ordering, responsible for some calibration and maintenance of laboratory equipment. May assist or write and execute protocols for procedural validations/verifications and instrumentation qualifications, and quality validation assessments (QVAs).
- Assist with audit readiness of laboratory area and act as SME during audits.
- Utilize a range of electronic systems such as document/equipment management software, LIMS, Empower, and ERP. May be administrator for area-specific software systems and on notifications for responding to alarms.
- Author, review and act as business owner for document changes; write/execute change controls, CAPAs, and utilize other quality systems.
- Resolve routine, non-routine and more advanced problems independently by utilizing appropriate resources. Provide problem solving and technical skills to support and/or lead the resolution and documentation of investigations.
- Represent Quality Control in team meetings and projects, providing technical perspective and expertise. Work on special projects as needed. Lead some continuous improvement efforts.
- Maintain and increase personal scientific, regulatory and compendial expertise, and contribute to team objectives. Extensive knowledge of industry practices for assigned area.
- Extensive knowledge in specialized functions. A wide and comprehensive acquaintance with, and understanding of, both general and specific aspects of the job and their practical application to complex problems and situations ordinarily encountered. Demonstrates flexibility to handle changing priorities without impact to other projects. Follows established procedures.
- Team player who can work independently with quality and attention to detail. Strong communication skills both oral and written, professional conduct. Effectively and efficiently participate in assigned tasks in a quality manner. Solid interpersonal skills, ability to take a lead role and interact with a diverse group of individuals at various levels (including key-stake holders, inter-organizational and outside contacts such as vendors or CMO representatives). Represents the organization in providing solutions to difficult technical issues.
- Actively promote safety rules and awareness. Reports and takes initiative to correct safety & environmental hazards. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
- Actively demonstrate the values of accountability, quality, efficiency, customer service, collaboration, and safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
qualifications:
Basic Qualifications
- Typically requires 5-8 years with a BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
Other Requirements
- Routinely scheduled work may be required on evenings, weekends, and/or holidays, including during adverse weather conditions. Some non-routine travel may be required.
- Work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials and must be able to lift/move materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals/waste containers.
skills: Chemistry, Microbiology, 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.

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