GMP Operational Quality Senior Specialist Contract 25048
GMP Operational Quality Senior Specialist Contract 25048
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Job Description
Job Description
The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of activities and supports new/existing project initiatives. The GMP Operational Sr. Quality Specialist Contractor is recognized as a subject matter expert in the principles and application of quality assurance and compliance. The Sr. Quality Specialist Contractor coordinates GMP activities in support of commercial disposition. This position reports directly to the Senior Manager GMP Operational Quality.
Key Responsibilities:
- Participates in crossfunctional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Vertex or at contracted suppliers
- Enforces Quality Agreements between CMOs/Suppliers and Vertex as needed
- Assists Change Control owners with ensuring compliance to change procedure requirements
- Supports change control assessments implementation approval and closure
- Supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS. Supports quality oversight for rootcause analysis and product impact assessment for investigations as a result of deviations OOS and OOT investigations ensuring appropriate CAPA actions are identified.
- Ensures appropriate CAPA actions are identified and addressed.
- Approves investigations/CAPAs.
- Maintains Quality Metrics to support on time release deliverables
- Conducts GMP document review including Master Batch Records Executed Batch Records Validation Protocols and Reports
- Identify and communicate risks and assist with risk mitigation plans as necessary
- Identifies and facilitates continuous improvement efforts
- Helps represents Vertex Quality on crossfunctional working teams applying strong communication and collaboration skills.
- Support continuous improvement projects
Minimum qualifications:
Knowledge and Skills:
- Experience supporting multiple projects/teams within stated objectives and timelines
- Experience supporting crossfunctional team members and collaborate effectively
- Good communication skills (written and verbal) and the ability to exchange potentially complex information
- Able to integrate 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 fastpaced environment and meet quality accuracy and timeliness objectives
- Expanded conceptual knowledge of cGMPs in a pharmaceutical setting
- Proficient in leading event investigations Root Cause Analysis (RCA) and CAPA
Education and Experience:
- Bachelors degree in scientific or allied health field (or equivalent degree)
- Typically requires 3 years of experience or the equivalent combination of education and experience
- Experience providing Quality support and oversight of GMP manufacturing operation including batch release
- Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting
- Knowledge of cGMP requirements governing oral drug products manufacturing practices
Pay Range
$55$65/hr
Requisition Disclaimer
This job posting is for a temporary role with a thirdparty 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 thirdparty 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 jobrelated 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 CV/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 Vertexs Careers Privacy Notice. 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 employmentrelated 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 ThirdParty Vendors
Required Experience:
Director
Employment Type
Full-Time
