Senior Quality Assurance Specialist - Stability Coordinator 9/10/2016

MilliporeSigma Saint Louis, MO

Company
MilliporeSigma
Job Classification
Full Time
Company Ref #
150871
AJE Ref #
576129875
Location
Saint Louis, MO
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Stability Coordinator

The Stability Coordinator will coordinate stability operations activities and ensure quality products and systems. Activities to include protocol development, equipment management, internal and external testing coordination, scheduling, stability data compilation and analysis.

Primary Responsibilities/functions:

* Coordinate stability operation activities and ensure quality products and systems

* Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols;

* Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications;

* Prepare stability data graphs to estimate expiration dates and verify product shelf life

* Evaluate stability trends and prepare reports;

* Initiate action reports or deviation reports for any applicable nonconformance

* Assist with the filing and archiving of stability studies;

* Provide a quality review process for data generated in the stability group

* Work closely with team leader regarding work scheduling and assignments;

* Coordinate outside contract testing;

* Work with internal and external auditors; may be required to act as spokesperson on behalf of company;

* May recommend cost improvements and provide advice on routine operational procedures as related to stability testing;

* May oversee and train a small group (i.e., 1-3 administrative support / technical staff)

* May serve on project teams.

Knowledge/Skills/Abilities

* Must be proficient in Microsoft Office and other software using a personal computer;

* Requires intermediate to advanced Excel skills;

* Knowledge of and ability to work with equipment, supplies, components and technical areas that are utilized in the biotech industry, i.e., weighing equipment and controlled environmental chambers;

* Knowledge of FDA guidelines on Stability requirements is a plus;

* Must have program management skills and scheduling abilities;

* Able to develop and implement efficient functional systems;

* Quality minded with ability to perform work with detailed accuracy and in accordance with established procedures

* Must be able to analyze data and work with a high degree of accuracy;

* Organized and able to perform duties in a timely manner;

* Must be flexible and able to handle multiple activities;

* Able to exercise independent intellectual judgment based on their specialized skills in the field of science;

* Good verbal and written communication skills;

* Able to effectively communicate with team leader, other departments, and vendors;

* Job requires handling of investigational products, active ingredients, and common laboratory chemicals. The individual must be able to handle these items in accordance with normal safety precautions;

* Vision suitable for performing detailed inspections;

* May be required to move items weighing up to 25 lb.

Required Education/Experience/Training
Minimum Requirement:

Bachelors degree in biology, chemistry or related life science field plus 3-5 year relevant experience

Additional Preferred:

Experience in GMP quality control or quality assurance

MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.