QC Validation Specialist

  • location: Newbury Park, CA
  • type: Contract
  • salary: $31.65 - $37.24 per hour
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job description

QC Validation Specialist

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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Newbury Park, California
job type: Contract
salary: $31.65 - 37.24 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Primary duties of the position are focused around the qualification of QC analytical equipment, and method validation for the Quality Control Analytical and Microbiology departments. Primary activities would generally include but not limited to URS generation, IOQ protocol and reports, equipment classification and release, method validation protocols and reports, critical material qualification and other lifecycle activities as required. Plan schedules and arranges own activities in accomplishing objectives. Work within QC to maintain an efficient compliant laboratory (including but not limited to instruments, documentation, SOPs, etc).

  • This role will be responsible to drive analytical method validation of laboratory methodologies and instrumentation, the ideal candidate will have a background in method validation and will be familiar with GMP manufacturing requirements.
  • Ensure all laboratory equipment is maintained in a validated state and that all analytical methods transferred are in compliance with company and regulatory requirements. This role will be responsible for lifecycle management and new instrument qualification for a variety of analytical instruments, including HPLCs, PCR, plate readers, container closure testers and rapid microbial detection technology, for new and existing products within the quality control laboratory
  • The role will be responsible for protocol and report generation as well as authoring CMC submission and other technical documents as required.
  • Supports local QC process monitoring and process improvement through application of descriptive statistics and visualization and statistical process control using out-of-the-box-tools
  • Support development of best demonstrated validation practices within the QC validation department, based on current industry practices and guidelines
  • Support the execution and issue resolution (e.g. discrepancies) and completion approval of test plans/protocols
  • Support troubleshooting of analytical methods and instruments and support laboratory investigations as needed to provide scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical result investigations
  • Upgrading of analytical technologies within an established licensed technology platform
  • Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.
  • Support the analysis of QC data using statistical tools to identify trends and set limits for results, including data transcription/entry
  • Use sound scientific principles and statistical techniques to solve problems and make recommendations.
  • Lead small teams as needed to accomplish tasks.
  • Ensure Right First Time (RFT) in the method introduction and instrument qualification process
  • Complete all tasks in a timely and appropriate manner.
  • Support continuous improvement activities.
 
qualifications:
  • Typically requires a bachelor's degree and a minimum of 1-5 year of related experience. (Science/Engineer related degree is preferred)
  • The applicant must have excellent technical writing skills and be able to write generate technical documents and reports that meet company and regulatory requirements
  • In depth knowledge of analytical methods and operations with strong emphasis in problem-solving.
  • Knowledge about analytical method validation and critical reagent qualification.
  • Experience in problem solving (facilitation and application of tools)
  • Intermediate statistical knowledge and experience with data analysis.
  • Knowledge of Statistical Process Control and ANOVA
  • Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
  • Basic knowledge about regulatory requirements concerning analytical instrumentation, test methods and licenses
  • Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. cGMP, QSR, USP, 21CFR, ICH etc.
  • Ability to complete tasks with minimal direction, demonstration of basic project management skills.
  • Ability to multi?task in a highly dynamic and diverse environment
  • Attention to detail
  • Good organization and time management skills to meet deadlines.
  • Proficient in Microsoft Office.
  • Strategically and business-oriented thinking
  • Fluent in English
  • Normal office environment.
  • Position requires frequent usage of a personal computer
  • May be required to work or be assigned to a different shift as needed.
  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.
  • May be required to travel for business reasons, e.g. training and meetings.
  • May need to work in controlled or clean room environments requiring special gowning. May be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
  • May be exposed to dust, gases, and fumes.
  • Possible exposure to cool/hot storage conditions.
  • May be around moving equipment and machinery.
  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.
  • May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
  • Inside working conditions.
  • Will interact with other people (cross functional).
  • Pace may be fast and job completion demands may be high.
 
skills: Quality control, SOP, ICH Regulations, 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.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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