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Randstad US Quality Assurance - Clinical in Parsippany, New Jersey

Quality Assurance - Clinical

job details:

  • location:Parsippany, NJ

  • salary:$40 - $42.19 per hour

  • date posted:Monday, November 15, 2021

  • experience:3 Years

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:39208

job description

Quality Assurance - Clinical

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. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now!

location: Parsippany, New Jersey

job type: Contract

salary: $40.00 - 42.19 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

  • Ensure SLS quality systems are maintained consistent with cGMPs, company policies, site procedures and regulatory guidance. The quality systems to be maintained include, but not limited to, laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, notification to management, corrective and preventive actions (CAPAs), site quality review team (SQRT) and change management.

  • Ensure testing/administration is conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance.Position Responsibilities:

  • Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include (but not limited to) stability study change control, equipment change control, corrective and preventive actions, quality notification reports, testing notes, instrument/facility qualifications, analytical method validation and transfers and laboratory investigation reports.

  • Ensure site quality systems are consistent with cGMPs, company policies, site procedures and regulatory guidance.

  • Able to interpret quality requirements, both internal and external, and apply them to real life situations in the pharmaceutical industry.

  • Experience with the principles and application of quality risk management.

  • Work together with the SLS management to assure that objectives and metrics are met.

  • Contribute to quality assurance management team initiatives and objectives.

  • Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed timeframes.

  • Ensure testing/administration are conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance.

qualifications:

  • Bachelor's degree or higher in Chemistry/Biology or related discipline.

  • Experience: 2-5 Years of related analytical chemistry/microbiology experience with a Bachelor's degree or 2-5 years working in a Quality Assurance position in the pharmaceutical industry. This experience should include authoring/approving analytical investigations and deviations.

  • Experience with electronic laboratory support systems (gQTS, gLIMS, PDOCS) preferred.

  • Experience with Human Performance and Risk Management principles is highly desirable.

  • QC/QA experience in a drug product or API manufacturing environment is desirable.

  • Excellent written and oral communication skills with the ability to summarize complex situations in an easily understandable narrative.

  • Must be comfortable interacting with all levels of management in the organization

skills: CAPA, Biology, Chemistry

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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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