Chemist / Microbiologist

PfizerRochester, MI
14hOnsite

About The Position

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. What You Will Achieve In this role, you will: Assist in preparation of media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories by autoclave cycles. Assist in maintenance of Master cultures Isolates and preparation of Cryo vials. Manage receipt, storage and handling of Bio ball cultures. Perform water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test and Assays, CCIT and micro challenge studies. Ensure training records are updated and correctly filed to reflect current testing capabilities. Perform sampling and labeling of materials as per defined procedure and verification of all the equipment / instruments. Interpret and evaluate data in terms of accuracy, precision, trends and potential Good Manufacturing Practices also cGMP} impact and recommend appropriate corrective actions. Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices and Good Laboratory Practices requirements and that they are filed in accordance to existing policies. Review and revise Standard Operating Procedures (SOPs), analytical methods and related procedures/documents, to keep them current. Perform analyses on finished products, raw materials, and components including entry, review, and/or approval of data in a computerized database and generate EMS reports. Conduct Microbiological protocols on an as needed basis. Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Requirements

  • Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience .
  • Demonstrated technical skills in method validation and testing
  • Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
  • Knowledge of Good Manufacturing Practices and its application standards, processes and policies
  • Excellent organizational skills and strong ability to multi-task
  • Strong written and verbal communication skills

Nice To Haves

  • Laboratory work experience with analytical HPLC (High Pressure Liquid Chromotography) technique
  • Experience leading continuous improvement projects
  • Knowledge of lean manufacturing, six sigma methodologies, and statistics.

Responsibilities

  • Assist in preparation of media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories by autoclave cycles.
  • Assist in maintenance of Master cultures Isolates and preparation of Cryo vials.
  • Manage receipt, storage and handling of Bio ball cultures.
  • Perform water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test and Assays, CCIT and micro challenge studies.
  • Ensure training records are updated and correctly filed to reflect current testing capabilities.
  • Perform sampling and labeling of materials as per defined procedure and verification of all the equipment / instruments.
  • Interpret and evaluate data in terms of accuracy, precision, trends and potential Good Manufacturing Practices also cGMP} impact and recommend appropriate corrective actions.
  • Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices and Good Laboratory Practices requirements and that they are filed in accordance to existing policies.
  • Review and revise Standard Operating Procedures (SOPs), analytical methods and related procedures/documents, to keep them current.
  • Perform analyses on finished products, raw materials, and components including entry, review, and/or approval of data in a computerized database and generate EMS reports.
  • Conduct Microbiological protocols on an as needed basis.
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Benefits

  • We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
  • Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
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