Pfizer CQ Investigations Lead in Rocky Mount, North Carolina
The CQ Lead Investigator supervises a group of Quality Engineers who perform investigations on laboratory deviations and laboratory and manufacturing investigations related to Out of Specification (OOS), Out of Limit (OOL) and Questionable (Q) results at Rocky Mount site. The person needs to have good leadership skills to facilitate team work among colleagues within the Rocky Mount site as well as external colleagues within and outside Pfizer organization.
• Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with management as soon as they are identified.
• Follows procedures at all times, adopting cGMP, cGDP practices.
• Possesses technical competencies of analytical techniques, such as non-instrumental wet chemistry techniques, Manual Titrations, pH, Conductivity, Autotitrations, UV-Vis, Polarimeter as wells as more advanced techniques, such as GC, HPLC, AA, FTIR, ICP-MS, etc.
• Has familiarity with package components test and requirements.
• Has general understanding of manufacturing processes and documentation.
• Provides guidance for investigational strategy; reviews and approves investigational protocols and reports; ensures correct root cause identifications and implementation of appropriate CAPAs
• Tracks and trends investigational metrics.
• 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.
• Proficient with Microsoft Office
• Experience in TrackWise, LIMS, SAP DMS, rDoc and 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
• Proficient with investigational methodologies
• Resourceful and innovative approach
• Ability to work cross-functionally with a diverse team
Stand up for up to 4 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
Last Date to Apply for Job: July 28, 2017
Grade: Hospira Grade 16
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.
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.