Pfizer Document Control Supervisor in McPherson, Kansas
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 biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Accountable for: Ensuring all plant changes to documentation are executed appropriately and effectively according to Plant, Corporate and Regulatory requirements.
Responsible for: Direct training and supervision of documentation personnel, Edit, control and distribution of all SOPs, TCPs, Monographs, Specification Sheets, Data Sheets and Batch Records for the plant operations.
Process owner for Documentation process and responsible for process enhancements
Oversees the review and approval of plant documentation that apply to product, procedures, processes, equipment, facility changes, art work, labeling and all affected systems that undergo changes.
Ensure plant documents are executed appropriately by identifying and applying the appropriate sequence of required deliverables and are implemented in a systematic way to assure effective and timely closure
Oversees the evaluation of process/procedure changes as necessary and assure document changes are implemented according to corporate, site and regulatory guidance. .
Act as primary document control representative for major plant and corporate projects, track/trend and report site change management metrics to site Management staff identifying/elevating documents potentially interfering with critical path metrics.
Additional responsibilities as defined by Quality Management.
Requires bachelor's degree in scientific field or equivalent GMP biopharmaceutical experience. Requires a minimum previous 2 years in a leadership position. The preferred candidate will have a minimum 5 years with direct involvement overseeing documentation activities in a regulated industry..
Strong oral, written, communication, presentation and interpersonal skills. Capable of interfacing with multiple levels of people within the organization, including Corporate management, third party customers, and plant personnel. Superior problem solving skills required. Must be capable of organizing data from multiple sources, extracting key information to report metrics. Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access and Paradox) Experience using data analysis computer tools and statistical analysis is preferred. Experience working in a cross-functional, matrix environment
This position will be responsible for ensuring all plant documentation changes are executed appropriately and effectively according to Plant, Corporate and Regulatory requirements. Independent action and sound decision-making are essential for success in the position as decisions can impact regulatory filings, product release and compliance with GMP.
Advanced analytical skills will be required to make competent decisions based on a review of analytical data.
Review and evaluate sensitive and confidential information as it pertains to specific plant document changes. Make recommendations to ensure document changes meet the intent of Good Manufacturing Practice outlined in site, corporate and regulatory guidance.
Decisions are made based upon knowledge and experience with input from the appropriate Quality Management personnel
Considerable mental/visual concentration, coordinating manual dexterity with mental/visual attention.
Normal office environment
Subject to frequent interruptions of normal routine.
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.
Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.
Legacy Hospira grade 15A 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.