Scientist - Quality Control Validation

Job description

Scientist - Quality Control Validation

Your role:

Quality Control in St. Louis, MO, supports manufacturing of custom products including active pharmaceutical ingredients, excipients, and raw materials used within the health care industry.

 

This scientist position within Quality Control department is responsible to perform analytical validations to support the testing of samples of raw materials, intermediates, stability and finished goods per ICH / cGMP guidelines and regulations.

 

The candidate must have experience in performing analytical method validations including cleaning validation to support release of commercial products, preferably previous pharmaceutical experience.  The candidate will be required to write method specific protocols, operating procedures, and final reports for assigned method validation. They will also execute and review testing, per good documentation requirements, required per the required validation protocol.  Additionally, the ideal candidate will lead technical troubleshooting and process improvements to improve laboratory performance and manage project milestones for internal and external customers to ensure on quality and on time success.

 

Additional tasks associated with the position may require drafting and reviewing analytical methods or equipment procedures and protocols as assigned for non-validated methods. The candidate may be required to perform technical review of assays and other GMP documentation. The candidate will be required to work in accordance with current GMPs and demonstrate / champion proper laboratory safety and housekeeping practices.

Experience with implementation of new analytical equipment, comparison of technical specification of equipment and software upgrades, and performance of equipment equivalency testing for previously validated methods is preferred.

 

Physical Attributes:

·  Chemical environment- Must be able to perform tasks while wearing personal protective equipment such as respirator or chemical protective clothing for extended periods.
·  May require occasional lifting and pushing of up to 40 pounds.

 

  Who you are:

 

Required Skills:

·  BS/BA degree in chemistry, biochemistry, biology, or related life science.
·  5+ years of GMP experience in pharmaceutical, biopharmaceutical or similar industry.
·  1-2 years of experience performing analytical method validation.

 

Preferred Skills

·  The ideal candidate has a broad range of experience performing, reviewing, and troubleshooting analytical methods to support bio-organics, protein, or bio-conjugate products.  These techniques may include UV, HPLC, GC, TOC, AA, and wet chemistry techniques. 
·  Strong technical writing, root cause analysis and scientific reasoning
·  Experience in lean lab practices and continuous improvement initiatives

RSRMS

Job Requisition ID: 205184

Location: St. Louis

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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