Quality Control Specialist

  • location: Newbury Park, CA
  • type: Contract
  • salary: $24.81 - $29.19 per hour
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job description

Quality Control Specialist

job summary:
Quality Control Analyst I

Job Summary

Conduct specific biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs.

 
location: Newbury Park, California
job type: Contract
salary: $24.81 - 29.19 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc.
  • Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete all testing, including special project / protocol testing in a timely and appropriate manner.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Write exception documents.
  • Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
  • Perform laboratory and manufacturing audits as required.
  • Audit and update, as required, plant SOPs.
  • May perform equipment maintenance and calibrations as required.
  • May perform other duties as assigned.
 
qualifications:
Education & Qualifications

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years experience.
  • Appropriate additional certifications may be required pursuant to state or federal regulatory requirements
  • Ability to handle multiple tasks concurrently, and in a timely fashion.
  • Computer literate.
  • Must be detail oriented, conscientious and have high reading comprehension skills.
  • Must have basic understanding of laboratory instrumentation.
  • Must be able to communicate effectively with supervisors and peers.
  • Must be able to read, write, and converse in English.
  • Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.
  • Must have the ability to navigate electronic mail systems and intranet for communication purposes.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Knowledge of cGMP manufacturing.
  • Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
  • Knowledge of basic chemical and biological safety procedures.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must have passion to innovate and drive for solutions.
  • Must display personal accountability for results and integrity.
  • Must display eagerness to learn and continuously improve.
  • Must have uncompromising dedication to quality
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
 
skills: SOP, 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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