GMP QA Operations Senior Specialist

Found in: Resume Library US A2 - 1 week ago

Boston Massachusetts, United States Vertex Pharmaceuticals Full time
Job Description:
The Sr. Specialist GMP QA Operations works with a high degree of independence, while providing oversight of the development, implementation, and maintenance of relevant quality initiatives in support of their function. The Senior Specialist completes work in a resourceful, self-sufficient manner and is able to design alternative approaches to achieve desired outcomes. They are adept at troubleshooting problems, coordinating and executing activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements.

 

Key Duties and Responsibilities:

 

Master and Executed Batch Record review and resolution of comments/issues

Archiving of batch documents in electronic document system

Track data for the purpose of metrics generation

Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status

Disposition Decision and status change in Oracle

Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.

Supports change control assessments, implementation and closure

Identifies and facilitates continuous improvement efforts

Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed

Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.

Support continuous improvement projects

 

Knowledge and Skills:

 

Experience supporting multiple projects/teams within stated objectives and timelines

Experience supporting cross-functional team members and collaborate effectively

Good communication skills (written and verbal) and the ability to exchange potentially complex information

Able to integrates activities with other groups, departments and project teams as needed

Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent

Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives

Expanded conceptual knowledge of cGMP's in a pharmaceutical setting

Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

 

 

Education and Experience:

 

Bachelor's degree in scientific or allied health field (or equivalent degree)

Requires experience in batch release, GMP environment, or the equivalent combination of education and experience

Pay Range:
$50-$60

Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

 

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your RESUME/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at .

 

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.

 

No C2C or Third-Party Vendors

 

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