QC Scientist II Details

QC Scientist II

Pfizer - Andover, MA

Employment Type : Full-Time

ROLE SUMMARY The qualified candidate will provide support for analytical method testing in a cGMP quality control analytical (QCA) laboratory. This includes analytical testing support for multiple products including Plasmid DNA, Vaccines, mAbs, and Proteins. The testing includes various techniques including Cell Culture, Bioassay, UV spectrophotometry, and ELISA methods. This position requires working collaboratively with the QCA team and actively participating in scheduling, visual management, metrics, and continuous improvement activities. ROLE RESPONSIBILITIES

• Perform and Support lab testing of in process, release and stability samples: execute testing, review data and documents for compliance and accuracy. Support laboratory investigations
• Support assay troubleshooting and look for Continuous Improvement (CI) opportunities/method improvements.
• Identify technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct.
• Maintain all related data and records in compliance with cGMPs and quality procedures
• Perform laboratory support functions and maintain work area in compliance with cGMP and quality procedures.
• Collaborate with site functional areas and customers to support site goals and objectives and transfer timelines.
• Meet all timelines and deliverables in support of Andover gene therapy manufacturing.

QUALIFICATIONS B.S. in Biology, Chemistry or related scientific discipline with a minimum of 3 years of applicable laboratory experience or M.S with minimum of 2 years.

• Knowledge of various analytical techniques and practical application of relevant analytical techniques (analytical testing and troubleshooting)
• Preferred laboratory experience includes Cell Culture, Bioassay, Aseptic Techniques, and ELISA
• Experienced in cGMP, regulatory guidance and audits
• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
• Excellent communication skills both oral and written
• Strong understanding of continuous improvement tools and skills preferred (standard work, visual management, DMAIC)

Work Location Assignment: On Premise
PHYSICAL/MENTAL REQUIREMENTS Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.). Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/A Relocation support available Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. 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 #LI-PFE