CQ Senior Analytical Scientist
Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region). Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.
The CQ Senior Analytical Scientist, functions as a Subject Matter Expert for areas of evaluation of testing methods, including but not limited to internal test methods, compendia methods, and implementing updates of test methods for improvement through Global Quality Tracking System (QTS) and PDOCS change control process. The role requires interactions with colleagues within the Rocky Mount site as well as external colleagues within and outside the Pfizer organization.
- Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.
- Follows procedures at all times, adopting cGMP, cGDP practices.
- Has an understanding of Compendial Monographs to include: United States Pharmacopeia (USP), Pharmacopeial Forum (PF): European Pharmacopeia (EP), Pharm Europa, Japanese Pharmacopoeia (JP), and British Pharmacopoeia (BP)
- Has understanding of basic non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter as wells as more advanced techniques, i.e. GC, HPLC, AA, FTIR, etc.
- Has an understanding of Method Verifications, Method Transfers, Method Validations, Protocols, and Common Technical Document’s (CTD’s)
- Possess good trouble shooting skills for complex compendial methods
- Minimum of 8 years’ experience in a science related position, pharmaceutical industry preferred.
- 5 years’ experience in a manufacturing site.
- 4 or more years in a pharmaceutical facility.
- Minimum 2 years leadership experience
- BS degree in science field is required and advanced degree (MS or Ph D degree) preferred
- Excellent verbal and written communication skills and attention to detail.
- Experience with Compendial Monographs and General Chapters
- Proficient with Microsoft Office.
- Experience in SAP, QTS, DMS, PDOC system and Change Control preferred
- Capable of organizing data from multiple sources, extracting key information and writing reports and summaries.
- Demonstrated ability to write logically and consistently.
- Strong critical thinking and problem solving skills.
- Resourceful and innovative approach.
- Ability to work cross-functionally with a diverse team.
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. Have the ability to perform mathematical calculations and ability to perform complex data analysis
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
OTHER JOB DETAILS
Last date to apply for the job: August 13, 2021