Senior Specialist GMP Operational Quality contract 24817
Senior Specialist GMP Operational Quality contract 24817
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description
The Senior Specialist is recognized as having a functional knowledge in the principles and applicationofqualityassuranceandregulatorycompliance.TheSenior Specialist ensurestimelydeliveryof activities to support developmental programs.
The Senior Specialist supports or executes a wide range of straightforward quality activities and supports new/existing project initiatives. This role is responsible for the of Quality systems to support production and product advancement as well as the performance of product disposition of clinical products which includes drug substance drug product intermediate (spray dried dispersion) bulk drug product and finished goods.
The Senior Specialist will demonstrate strong collaboration with key cross functional colleagues from Pharmaceutical Sciences CMC Regulatory GDP Finish Goods Supply Chain and R&D Quality to compliantly advance programs through the product lifecycle. The Senior Specialist work with CMC and Quality partners to ensure that compliance and business requirements are optimized. The Senior Specialist will align with internal Quality functions Vendor Management Inspection Readiness and Audit /Inspection Management to support all quality related activities associated with the programs.
The ideal candidate will possess a working knowledge of early phase to commercial GMP drug substance and drug product manufacturing regulations and good written and verbal communication skills. Prior Quality experience supporting multiple projects and teams involved in drug development activities.
Key Responsibilities:
- Supports quality oversight for rootcause analysis and product impact assessment for investigations as a result associated with 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 crossfunctional working teams applying strong communication and collaboration skills.
- Support continuous improvement projects.
- Performs the review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records release data inprocess controls testing and stability data)
- Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance drug product intermediate drug product and finished goods.
- Supports GMP document review including certificate of analysis
PREFERRED QUALIFICATIONS:
- 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 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 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.
- Operational QA experience in analytical or manufacturing setting with experience in small molecule Experience with biologics devices gene therapy a plus.
- Practical GxP knowledge and understanding across lifecycle of the product including the application of:
- GMP regulations and application to
- Root Cause Analysis methodology and tools.
- Analytical techniques and data review
- Ability to evaluate routine quality matters and make decisions utilizing riskbased
- Ability to communicate crossfunctionally to a wide variety of
- Relationship management/conflict management
MINIMUM QUALIFICATIONS:
Bachelors degree in a scientific or allied health field (or equivalent degree) and 4 years of relevant work experience or equivalent combination of education and experience.
Pay Range
$6070/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
