Job description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
Quality Control analysis of raw material, in-process, API, stability and environmental samples
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Must have demonstrated proficiency in multiple high complexity technology (e.g. HPLC, GC, advanced spectroscopy, bioassay potency, bacterial endotoxin, etc.) and in multiple low to medium complexity technologies (e.g. titrations, wet chemistry/physical testing).
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LIMS and Statistical expertise is a plus
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. Your knowledge of quality control will be helpful to support our quality programs. Your ability to analyze chemical, biological or microbiological products will help us manage our quality. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to its patients. Your qualifications of unique Quality Control instruments will help us meet accuracy specifications for sample management, retains managements, interpretation and evaluation. You will also be relied on for establishing requirements for the transfer of methodology from R&D. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
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Responsible for conducting routine sampling and micro and chemistry testing to support production operations and stability program.
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Performs activities related to IMEx in support to the QC PCT as established by the applicable guidelines.
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Responsible for execution of individual small projects to support QC operations.
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Projects may include but not limited to:
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Sampling and testing activities related to approved studies, validations and qualifications
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Drafting equipment and method validation documents, management of the site Stability
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Program, Drafting master documents applicable to QC, Supporting and conducting lab RFT, Lean, and 5S projects, Test method development, troubleshooting and improvements, and managing gLIMS templates. This position will also work with in a fast-paced, customer- oriented, team laboratory environment to analyze, raw materials, packaging materials, in- process materials and API samples in support of the company's quality program.
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Perform, document, record check, and troubleshoots qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation.
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Interprets and evaluates data in terms of accuracy, precision, trends, and potential GMP impact and recommends appropriate corrective action where necessary
How You Will Achieve It
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Assist in preparation of media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories by autoclave cycles.
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Assist in maintenance of Master cultures Isolates and preparation of Cryo vials.
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Manage receipt, storage and handling of Bio ball cultures.
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Perform water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test and Assays, CCIT and micro challenge studies.
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Ensure training records are updated and correctly filed to reflect current testing capabilities.
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Perform sampling and labeling of materials as per defined procedure and verification of all the equipment / instruments.
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Interpret and evaluate data in terms of accuracy, precision, trends and potential Good Manufacturing Practices {also cGMP} impact and recommend appropriate corrective actions.
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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.
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Review and revise Standard Operating Procedures (SOPs), analytical methods and related procedures/documents, to keep them current.
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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.
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Conduct Microbiological protocols on an as needed basis.
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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.
Qualifications
Must-Have
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Applicant must have High School Diploma (or Equivalent) with six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.
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Demonstrated technical skills in method validation and testing.
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Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations.
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Knowledge of Good Manufacturing Practices and its application standards, processes and policies.
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Excellent organizational skills and strong ability to multi-task.
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Strong written and verbal communication skills.
Nice-to-Have
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Laboratory work experience with analytical HPLC (High Pressure Liquid Chromatography) technique.
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Experience leading continuous improvement projects.
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Knowledge of lean manufacturing, six sigma methodologies, and statistics.
PHYSICAL/MENTAL REQUIREMENTS
Physical capability to lift 50lbs weight.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability work in single shift with occasional weekend and extended hours.
PHYSICAL/MENTAL REQUIREMENTS
Must be able to lift 50 pounds
Work Location Assignment: On Premise
Last Date to Apply: May 30, 2023
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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