Senior Associate Stability Administration Pfizer
Parsippany, NJ

Job Description

ROLE SUMMARY

Independently supports PGS and PGS customers in the design and change management of applicable pharmaceutical stability programs; fields stability-related queries concerning marketed pharmaceutical products and active pharmaceutical ingredients; represents Stability Administration on complex projects and PGS project teams internal and external to SLS; independently works with Customer Sites to ensure and reconcile that all stability commitments are met; prepares submission-ready stability commitments, protocols, and reports.

ROLE RESPONSIBILITIES

* Acquires, demonstrates, and trains others on a fundamental understanding of pharmaceutical stability and effective use of applicable computer applications and systems
* Serves as single point-of-contact for stability-related questions on assigned products
* Agile learner; acquires the necessary accounts and permissions to access databases (e.g. PDOCS, LIMS, PLS, GDMS, etc.) and other information sources that relate to product stability and assembly, approval, and submission of regulatory stability reports and protocols; assists new colleagues with training and use of these applications upon request
* Accountable and reliable for timely, accurate and complete work
* Independently designs and authors protocols and commitments for stability studies;
* Independently supports LIMS change control; assures consistency between approved stability protocols and applicable SLS systems
* Applies skills and discipline knowledge to complete assigned work; independently researches the necessary databases (e.g. LIMS) and other sources for information related to the stability report, protocol and commitment preparation and regulatory submission
* Responsible Person for gQTS investigations and change management activities
* Creates and maintains assigned controlled documents and records
* Performs regression analysis of stability data and recommends release limits where necessary
* Independently communicates with customers to identify study requirements and convey pertinent information about data availability
* Represents SLS Stability Administration on project teams
* Proactively identifies and resolves problems; delivers creative solutions; contributes to SLS process and procedure improvements
* Confidently supports regulatory and customer audits and inspections

BASIC QUALIFICATIONS

* B.S. in a Science field is required, Chemistry, Biochemistry, Biology or similar technical field is preferred
* Minimum of 7 years of experience in the pharmaceutical industry is required
* Familiarity with GMPs and applicable regulations and guidelines (e.g. CFR, EMEA and ICH publications), and standard operating procedures is required
* Strong communication (oral and written) and teamwork skills
* Demonstrated critical thinking skills; close attention to detail and accuracy
* Demonstrated ability to work both independently and in a team environment; able to coach other team members and to receive coaching where appropriate; self motivated and willing to learn new and changing responsibilities
* Flexibility to respond to constantly changing conditions and priorities
* Demonstrated commitment to values based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core Competencies

PREFERRED QUALIFICATIONS

* M.S. Degree in Chemistry, Biochemistry, Biology or similar technical field
* Lab testing or site quality experience is preferred
* Deviation investigations and change management experience
* Aptitude for computerized systems
* Able to manage a heavy workload and short turn times with agility and optimism
* High proficiency in Microsoft applications such as Word, Excel, Visio, Outlook, and PowerPoint
* Working knowledge of Laboratory Information Management Systems (LIMS), including ability to pull data from LIMS
* Working knowledge of lab tests, procedures, and data results
* Familiarity with document management systems (PDOCS/Documentum) and Quality Tracking Systems (gQTS/Trackwise) highly desired
* Knowledge of pharmaceutical stability operations and associated industry regulations including cGMP, 21 CFR, ICH, and other global regulations highly desirable

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.

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.

Other Job Details:

* Last Date to Apply for Job: 7/24/2019
* Additional Location Information: Role can be based in Parsippany, NJ or Kalamazoo, MI
* Eligible for Employee Referral Bonus

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.