Pfizer QC Scientist IV in Andover, Massachusetts
The qualified candidate will provide support for new product analytical method transfers and technical support in a cGMP quality control analytical (QCA) laboratory. This support includes participating in method transfers, validations and qualifications in support of process validation readiness.
Collaborate with site functional areas such as analytical research and development, quality and manufacturing operations to support site plan of record.
Provide audit support for board of health inspections and regulatory responses.
Perform laboratory testing in support of transfer/ validation protocol execution: author test methods, train analysts, review data and documents for compliance and accuracy.
Provide technical support for new products, assay troubleshooting, investigations and method improvements.
Support installation and/or sustainability of Integration manufacturing excellence (IMEx) elements within the group.
Contribute toa continuous improvement culture within the group through the use of continuous improvement tools
Identify technical issues, method performance issues, trending, instrument malfunctions and methodology problems and participate in the investigation to resolve and correct.
Maintain all related data and records in compliance with cGMPs and quality procedures
Write and review technical documents, transfer plans, test methods, validation protocols and reports in support of new product transfers, co-validation, process validation, qualification, verification, Investigations, change controls and regulatory submissions.
Represent the Quality Control Analytical department in cross functional and site product meetings.
Support change controls and instrument validation.
Meet all timelines and deliverables in support of Andover plan of record.
B.S. in Biology, Chemistry or related scientific discipline with a minimum of 8 years of applicable laboratory experience or M.S with minimum of 6 years.
Extensive knowledge and practical application of relevant analytical techniques, method transfer, and validation.
Experience in laboratory analytical testing, assay troubleshooting and investigations.
xperience with cGMPs, regulatory guidance and audits.
Expertise in HPLC, Capillary Gel Electrophoresis, Peptide mapping and UV Spectrophotometry.
Expertise in ELISA and Bioassay preferred
Strong technical writing skills and investigations.
Demonstrated leadership skills in decision making, planning and prioritization with a focus on team success in meeting defined metrics and timelines.
Proficiency with computer systems (Microsoft Office applications, LIMS, SMART QC, etc.)
Knowledge of Software Empower, Softmax pro preferable
Excellent communication skills both oral and written.
Strong understanding of continuous improvement tools and skills preferred (standard work, visual management, DMAIC)
Last Date to Apply for Job: 05.28.2020
Eligible for Employee Referral Bonus
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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