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
Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Manage own time, professional development and accountable for own results.
- Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
- Responsible for maintaining laboratory compliance.
- Interpret and evaluate data in terms of accuracy, precision, trends, and potential Good Manufacturing Practices {also cGMP} impact and recommends appropriate corrective action where necessary.
- Perform, document, record check, and troubleshoot qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation.
- Perform testing for semi-finished goods and finished goods testing, validation sample, and other testing in accordance with approved procedures and test methods, and record the test results in timely manner.
- Investigate, analyze, problem solve, and communicate technical information to internal and external customers.
- Ensure all reagents and reference standards are valid and stored according to requirement.
- Comprehend and perform both routine and non-routine analyses from compendia and internal sources.
- Work effectively in a fast-paced, customer-oriented, team laboratory environment to analyze final drug products in the Drug Product Laboratory.
- Train and support less experienced analysts, working as a Certified Fellow Employee and mentor to aid in their development as analysts.
Qualifications
Role Summary
Summarize the primary purpose and key responsibilities of the role. It may be helpful to complete this section after you have finished the other sections of the document.
The incumbent is a member of the Quality Environmental Control (EC) Laboratory team. Under the supervision of the Environmental Monitoring (EM) Section Manager, and designated EM Shift Team Leader(s), the incumbent will be responsible for the collection, analysis, and inspection of manufacturing environmental conditions and materials according to Standard Operating Procedures (SOPs). Samples can include, both physical and microbiological, air, surface, and water system products, as well as commodity items. Aseptic gowning practices will also be adhered to for the performance of activities as required. Results are compared with specifications, documented as per data integrity regulations, and incumbent is responsible for providing communication of all process and specification deviations. Incumbent has working knowledge of EM, microorganism handling, aseptic technique, and quality concepts as to perform routine assignments with minimal supervision. Additional responsibility may include performing data trending activities and assisting with metrics reporting, as well as initiating and developing project plans for continuous improvements within the laboratory.
Role RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. Identify 5 – 8 key areas that highlight accountability and level of judgement required. Ensure GMP tasks and those required by regulation are clearly documented.
Collects Samples
Conducts routine environmental monitoring sampling within the laboratory and manufacturing areas in addition to collecting commodity and manufacturing material samples. Sample types include both physical and microbiological for the purpose of further quality analysis. Aseptic technique will be utilized for sample collection as required per supplied standard operating procedures.
Conducts Assays
Accurately performs routine environmental monitoring analysis of supplied samples according to provided standard operating procedures. Communicates effectively all basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems as they occur. May participate in active investigational analyses as well.
Analyses Results
Accountable for the accuracy and validity of testing results. Examines processed samples, both qualitatively and quantitatively, for the purposed of result and observation recording. Assists in data trending, analysis, and interpretation activities. Maintains accurate, complete, and legible records. Utilizes Laboratory Information Management Systems or other electronic record systems.
Safety Practices
Contributes to the housekeeping and cleaning of the laboratory areas. Safely handles/disposes of chemicals, biological agents, and waste. Complies with all Safety, Environmental, and Security policies as required. Communicates all safety concerns, incidents, and events as they occur.
Laboratory Support
Has opportunity to participate in non-routine activities/projects to support the team goals. May initiate and develop project plans for the purpose of continuous improvement within the department.
QUALIFICATIONS
Qualifications are job related, consistent with business requirements, and necessary for the performance of an essential function of this role. These include education requirements the role holder must possess, such as a Bachelors, Masters, or Doctorate degree, certifications, or other post graduate qualifications, the type and length of experience needed to perform effectively in the role, and the skills, knowledge, and attributes a candidate must possess to be competent in the position.
Education Requirements
- Minimum High School Diploma or GED with 2+ years of relevant experience required.
Experience Requirements
- Knowledge of basic microbiology, aseptic practices and/or environmental monitoring principles.
- Skills training in effective laboratory testing methods and computerized record keeping.
- 1-4 years of relevant experience in an industrial or laboratory setting preferred.
Technical Competency Requirements
- Ability to work in clean room environment (ISO 5) and proficient in aseptic gowning to perform sampling and able to maintain aseptic environmental conditions.
- Intellectual capability to perform complex mathematical problems and complex data analysis.
PHYSICAL/MENTAL REQUIREMENTS
PHYSICAL/MENTAL REQUIREMENTS
- Ability to stand for 3 to 4 hours at a time, sit for 2 to 3 hours at a time, walk long distances, and bend to obtain items from lower shelving/cabinets.
- Effective oral and written communications, and excellent inter-personal skills.
- Ability to lift weights up to 30 lbs. as part of routine.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Able to work overtime as needed to support production needs.
Work Location Assignment: On Premise
The salary for this position ranges from $19.71 to $32.86 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - North Carolina - Rocky Mount location.
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.
Quality Assurance and Control
"An Equal Opportunity Employer M/F/D/V"
