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Stability Coordinator

Pfizer


Location:
Boulder, CO
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

Under the direction and guidance of the QA Compliance Manager, the stability coordinator supports stability activities to ensure quality for all products manufactured at the Boulder site. The primary function of this job is to ensure stability samples set down are tested and that the Stability Schedule is maintained and adhered to for each product. Other responsibilities include protocol development, scheduling, stability data compilation and analysis, as well as assist with the Stability Program continuous improvement projects, such as extending the retest dating of current and future API.







**ROLE SUMMARY**



Under the direction and guidance of the QA Compliance Manager, the stability coordinator supports stability activities to ensure quality for all products manufactured at the Boulder site. The primary function of this job is to ensure stability samples set down are tested and that the Stability Schedule is maintained and adhered to for each product. Other responsibilities include protocol development, scheduling, stability data compilation and analysis, as well as assist with the Stability Program continuous improvement projects, such as extending the retest dating of current and future API.







**ROLE RESPONSIBILITIES**







+ Obtain and maintain training on the Stability laboratory management system (Thermo LIMS)



+ Review pertinent Stability documentation (SOPs, protocols, reports, etc.)



+ Coordinate stability samples for testing and storage (e.g. retrieve samples, sample management, etc.)



+ Evaluate stability trends and prepare reports



+ Complete year-end inventory of Stability samples



+ Assist with the filing and archiving of stability studies



+ Initiate action reports or deviation reports for any applicable nonconformance



+ Destroy Stability samples as needed based on status of studies and protocols



+ Perform other tasks necessary to support site compliance to corporate and regulatory requirements, such as Annual Product Records Review, inspection support, and QA Operations activities as needed







**QUALIFICATIONS**







+ Requires a Bachelor's Degree, preferably in Biology or Applicable Science



+ Strong organizational and problem solving skills to understand and carry out assigned duties effectively



+ Minimum 3 years of experience required, 5-7 years preferred







+ Strong written and verbal communication skills and professionalism are required



+ Ability to work and adapt in a fast pace environment



+ Knowledge of regulations for drug/pharmaceutical environment is preferred



+ Proven experience with various computer software applications to track and trend quality metrics (e.g. Microsoft Office)



+ Must be detail-oriented and have the ability to multi-task







+ Pharmaceutical or Medical Device experience is required







**PHYSICAL/MENTAL REQUIREMENTS**







+ Must be able to lift 50 lbs



+ Ability to bend, twist and use fine motor skills



+ Work environment is office space with occasional laboratory and manufacturing access



+ Must be able to use a computer keyboard and comprehend MS Excel







Must have ability to walk long distances throughout the day







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



This position has no travel



This position works standard shift hours, e.g. Monday through Friday and 8 to 5 p.m.







**EEO Statement**



**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.







**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.







**Additional Offer Details:**







+ **Last Date to Apply for Job: July 31, 2017**



+ **Grade: Hospira 06**



+ **Additional Location Information: Boulder, CO**







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.
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