TITLE/ROLE: Senior Specialist, GMP Operational Quality.
AREA: Quality Assurance
The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of 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 execution 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 root-cause 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 Client, as needed.
• Helps represents Client Quality on cross-functional 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, in-process 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, specifications.

PREFERRED QUALIFICATIONS:

• 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.
• Operational QA experience in analytical or manufacturing setting with experience in small molecule manufacturing. 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 Manufacturing.
• Root Cause Analysis methodology and tools.
• Analytical techniques and data review
• Ability to evaluate routine quality matters and make decisions utilizing risk-based approach.
• Ability to communicate cross-functionally to a wide variety of audiences.
• Relationship management/conflict management skills.
  Job Type: Contract
  Pay: $30.00 - $40.00 per hour
  Expected hours: 8 per week
  Work Location: On the roa

• Supports quality oversight for root-cause 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 Client, as needed.
• Helps represents Client Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects