Pfizer Biological Quality Technical Data Reviewer in Rocky Mount, North Carolina
The BQ Technical Data Reviewer reviews data from Biological Quality including raw material, finished product, environmental monitoring, diagnostic, etc. In addition to data review, this individual could be responsible for preparing solutions, performing analyses, as well as recording and processing data according to DEA, FDA, ICH, ISO, and and Annex 1 guidelines as needed.
Functions as a dedicated data reviewer for the Biological Quality Lab.
Prioritizes data review and testing with guidance supervisor
Assists in monitoring laboratory metrics associated with turnaround goals.
As needed, prepares solutions required for testing, performs the analysis, records data according to cGMPs, performs calculations and enters results into LIMS system.
Provides support to assure lab safety-either through safe use of chemicals and biological agents or recognition of hazards- and that the lab is compliant with DEA, FDA, OSHA, and ICH guidelines.
Minimum of 4 - 6 years experience in a Quality Control or laboratory and experience with a wide variety of microbiological techniques (e.g., Sterility, Bacterial Endotoxins Testing, Particulate Testing, antibiotic potency, Environmental Monitoring etc.) Knowledge of cGMPs and regulations outside of the US.
Good communication, organization and computer skills are required.
Knowledge of LIMS, PharmSpec, and Microsoft Office programs is desired.
Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives
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.
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.
Last Date to Apply for Job: June 2, 2018
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.