GMP Operational Quality Senior Specialist

Job Description

JOB TITLE: GMP Operational Quality Senior Specialist  

LOCATION: 50 Northern Ave, Boston, MA, 02210 

OPENINGS: 1 

DUTIES:  

• Supports the principles and application of quality assurance and regulatory compliance. 

• Supports or executes a wide range of standard activities and supports new/existing project initiatives.  

• Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations and Out of Specification (OOS)/Out of Trend (OOT) investigations ensuring appropriate CAPA actions are implemented/identified.  

• Supports change control assessments, implementation and closure.  

• Identifies and facilitates continuous improvement efforts for quality procedures and systems.  

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

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

• Support continuous improvement projects. 

REQUIREMENTS:  Employer will accept a Bachelor’s degree in scientific field such as Chemistry or Biology or related field and 5 years of experience in the job offered or in a GMP Operational Quality Senior Specialist -related occupation.  

Alternatively, employer will accept a Master’s degree in scientific field such as Chemistry or Biology or related field and 2 years of experience in the job offered or in a GMP Operational Quality Senior Specialist -related occupation. 

Position requires demonstrable experience in the following: 

Working in Quality Assurance roles specifically within pharmaceutical industry.  

Driving regulatory compliance per various Health Authority requirements and internal quality systems.  

Driving quality events including deviations, root-cause analysis, CAPA processes and change control.  

Reviewing and approving of technical documentation for product stability protocol generation and initiation, stability testing data, data trending reports and Annual Product Review reports.  

Driving oversight of stability testing, stability program management and associated analytical investigations.  

Collaborating with contract manufacturing laboratories, internal test labs, and Quality groups for GMP audits.  

Driving SOP development and process improvements related to Chemistry, Manufacturing and Control (CMC) activities.  

Executing analytical technologies such as HPLC, dissolution, GC, KF or related chemistry skills. 

Rate of Pay: $106974.00 - $139200.00 

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