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Pfizer

Makes cancer drugs, vaccines and other medicines

QC Chemistry Associate Scientist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSanford, NC, USA$60.2k - $100.4k /yr

About the Job

Requirements

  • Have 0–3 years of manufacturing, quality, or analytical testing experience in the biotechnology or pharmaceutical industry.
  • Have a BS/BA degree in Science or a related field with experience in the biotechnology or pharmaceutical industry, or another appropriate combination of education and/or experience in that industry; the degree is preferred.
  • Understand laboratory practices, analytical testing, and use of analytical equipment such as UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC, conductivity, glass washers, autoclaves, and balances.
  • Understand current Good Manufacturing Practices (cGMP), US, EU, and rest-of-world cGMP, pharmacopeias, ICH guidelines, analytical techniques and instrumentation, Laboratory Information Management System (LIMS), TrackWise, Microsoft Word, Excel and PowerPoint, Lean Six Sigma concepts, Lean Labs, project management, quality change control, investigations and documentation systems, and quality risk management including risk assessments.
  • Be able to perform mathematical problems and complex data analysis.
  • Be able to lift 30 pounds, stand or sit for 2 to 3 hours at a time, walk long distances, and bend to obtain items from lower shelving or cabinets.
  • Be able to wear appropriate personal protective equipment, including a lab coat, safety glasses, non-porous shoes, and gloves.
  • Be authorized to work in the United States by any employer and have permanent work authorization in the United States.

Responsibilities

  • Perform Good Manufacturing Practices (GMP) tasks to maintain compliant Quality Control and Stability laboratories.
  • Perform testing of clinical and/or commercial products, raw materials, and validation samples.
  • Analyze and interpret results and make decisions regarding accuracy, completeness, and compliance.
  • Create, review, and approve GMP documentation, including test records and, as assigned, validation protocols and reports, test methods, and equipment records; ensure adherence to Pfizer standards and guidelines.
  • Report issues to management and participate in issue resolution, including reporting out-of-specification results and participating in related laboratory investigations, reporting instrument issues, and assisting with troubleshooting.
  • Assess existing situations and suggest improvements to increase compliance and innovation.
  • Act in accordance with Pfizer’s values and OWNIT culture.
  • Detail requirements for LIMS builds and/or build and test new LIMS builds and LIMS Master Data changes.
  • Work Wednesday through Saturday, 8:00 a.m. to 6:30 p.m.; other days or minimal off-shift work may be required to cover business needs.

Desired Qualifications

  • Knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
  • Experience independently handling complex investigations and associating corrective and preventive actions (CAPA) within the work area under limited guidance.
  • Ability to demonstrate sufficient depth of knowledge in the scientific discipline and prior area of experience.
  • Ability to follow written procedures and learn from hands-on training.
  • Capability to solve complex mathematical and situation-dependent problems.
  • Ability to receive feedback and take accountability for actions and personal development.
  • Ability to make sound decisions based on procedures, guidance, and experience.
  • Awareness of personal limitations and ability to seek guidance from a senior scientist or management when appropriate.
  • Attention to detail and commitment to correctness and accuracy in tasks and documentation.
  • Ability to work as a team member and independently with minor guidance.
  • Willingness to use personal skills and knowledge to achieve individual and company goals.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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