QC Stability Coordinator in Grafton, WI at AMRI

Date Posted: 1/6/2020

Job Snapshot

Job Description

QC Stability Coordinator in Grafton, WI.


AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.


The primary responsibility of this position is to coordinate stability operations and to ensure the integrity of data obtained and reported for product stability. Related activities include protocol development, equipment management, internal and external testing coordination, scheduling, stability data analysis, deviation investigation, related revenue tracking, change control, and reporting. Additionally, the coordinator will act as designee for the Quality Control Manager as needed.


Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.


Major Duties and Responsibilities


1.     Coordinates all activities associated with the QC stability program, including scheduling and testing of stability lots.


2.     Manages all stability studies through execution of the following:

- Author stability protocols, interim/final reports, and summary tables;

- Perform data entry and review as needed;

- Perform out of specification/out of trend investigations;

- Act as stability-related change control owner;

- Provide testing support as needed;

- Provide training support as needed

               3.     Acts as subject matter expert regarding the stability program during    customer/regulatory audits and customer interfacing.


4.     Provides stability data for regulatory filings.


5.     Provides stability summaries for annual product review.


6.     Interacts with outside testing laboratories to coordinate shipment and testing of stability samples.


7.     Stability revenue management, including tracking monthly projections and collaborating with finance to ensure complete and accurate accounting. Serve as designee for the Quality Control Manager as needed.

Job Requirements

Qualifications
  • Bachelor's Degree in Chemistry, Biology or related sciences

  • Minimum of five years of relevant experience in a pharmaceutical testing laboratory

  • Experience and understanding of ICH stability guidelines

  • Experience with QC stability testing and sample management

  • Experience with out of specification/out of trend laboratory investigations

  • Ability to work independently and prioritize tasks to meet challenging timelines

  • Demonstrated strength with critical thinking, problem-solving, communication, and decision-making skills

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Shift:  

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

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AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.