Quality Contorl Scientist

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Apex Systems
Full Time

Job Description

Job#: 1276830

Job Description:

Quality Control Scientist

Apex Systems is seeking a QC Scientist near Webster, TX for a contract project with a global leader in pharma, biotech and consumer health . The QC Scientist is responsible for routine QC testing on in-process and release samples. Additionally, the QC Scientist is responsible for the QC department Training and Compliance. The QC Scientist must demonstrate strong technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

RESPONSIBILITIES
  • Strong technical expert and maybe perform assays such as Endotoxin, Flow Cytometry, Sysmex, Mycoplasma, Gram Stain, ELISA, Sterility, Phenotyping Assays.
  • Generate testing records and report results
  • Acting role as site SME for the Assays and support/own all complex investigations included but not limited to LIRs/OOS/Deviations/CAPAs/Change Controls
  • Support all client/internal/external audits and inspections.
  • Provide instrumentation care, maintenance, troubleshooting, and data interpretation
  • Work closely with Manufacturing and Quality Assurance staff to resolve quality issues about the facility and products manufactured
  • Strong technical writer (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
  • Ensures compliance with cGMP and safety requirements within the QC analytical laboratory
  • Participates and carries out continuous quality improvements in the QC laboratory
  • Participates in project specific, system, client, and vendor audits
  • Maintains QC analytical laboratories and facilities in an audit ready status at all times.
  • Conducts training on applicable SOPs, regulatory requirements and quality initiatives
  • Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
  • Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels
  • Ability to work within a team setting as well as independently
  • Other duties as assigned

REQUIREMENTS
  • Masters in a Life Sciences discipline and 3 or more years of experience working in an AD/QC laboratory (will consider reduced experience with increased levels of education in same field)
  • Safety Assay knowledge/experience preferred
  • Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology
  • Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices
  • Experience in writing SOPs/Protocols/Tech Transfers/Validation
  • Broad experience with biochemistry , as well as generating/reviewing the documentation that supports such work
  • Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks

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EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1276830
Originally Posted : 1 month ago

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