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.
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 to 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.
How You Will Achieve It
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.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associate's degree with 4 years of experience OR a bachelor's degree with 0+ years of 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-Have
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
PHYSICAL/MENTAL REQUIREMENTS
PHYSICAL/MENTAL REQUIREMENTS
Able to lift 25-30 lbs
This is a penicillin manufacturing facility. Any candidates applying must NOT be allergic to penicillin.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Monday – Friday (i.e. 0700-0330 negotiable) with occasional evening and/or weekend work.
Work Location Assignment:On Premise
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. This position requires permanent work authorization in the United States.
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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