Hydrogen Group
GMP Operational Quality Senior Specialist
The client is a global biopharmaceutical leader dedicated to developing innovative therapies. This position provides an opportunity to play a key role in supporting quality and compliance activities across multiple programs in a collaborative, fast-paced environment.
Base pay range:
$65.00/hr - $70.00/hr
Schedule:
Standard Office Hours
Duration:
24-Month Contract
Pay Range:
$65-70/hr
Key Responsibilities
Provide quality oversight for root-cause analysis and product impact assessments related to deviations, OOS, and OOT investigations, ensuring appropriate CAPA actions are implemented.
Support change control assessments, implementation, and closure.
Draft and revise Quality Agreements with external partners and suppliers.
Represent Quality on cross-functional teams, applying strong communication and collaboration skills.
Review executed batch documentation and testing data to support disposition of drug substance, intermediates, and finished products.
Ensure compliance through GMP document review, including certificates of analysis and specifications.
Contribute to continuous improvement projects and compliance optimization across functions.
Preferred Qualifications
Experience supporting multiple projects and cross-functional teams within defined objectives and timelines.
Strong written and verbal communication skills, with ability to present complex information effectively.
Ability to collaborate across groups, departments, and project teams.
Demonstrated capability to evaluate quality matters and solve problems using precedent and technical judgment.
Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
Proficiency in Root Cause Analysis (RCA), CAPA, and event investigations.
Operational QA experience in analytical or manufacturing settings (small molecule preferred; biologics, devices, and gene therapy experience a plus).
Practical GxP knowledge across the product lifecycle, including GMP regulations and application to manufacturing, RCA methodologies and tools, analytical techniques and data review, and risk-based decision making.
Effective communication across diverse audiences with strong relationship management skills.
Required Qualifications
Bachelor’s degree in a scientific or allied health field (or equivalent).
Minimum 4 years of relevant work experience, or an equivalent combination of education and experience.
Seniority level Mid-Senior level
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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Base pay range:
$65.00/hr - $70.00/hr
Schedule:
Standard Office Hours
Duration:
24-Month Contract
Pay Range:
$65-70/hr
Key Responsibilities
Provide quality oversight for root-cause analysis and product impact assessments related to deviations, OOS, and OOT investigations, ensuring appropriate CAPA actions are implemented.
Support change control assessments, implementation, and closure.
Draft and revise Quality Agreements with external partners and suppliers.
Represent Quality on cross-functional teams, applying strong communication and collaboration skills.
Review executed batch documentation and testing data to support disposition of drug substance, intermediates, and finished products.
Ensure compliance through GMP document review, including certificates of analysis and specifications.
Contribute to continuous improvement projects and compliance optimization across functions.
Preferred Qualifications
Experience supporting multiple projects and cross-functional teams within defined objectives and timelines.
Strong written and verbal communication skills, with ability to present complex information effectively.
Ability to collaborate across groups, departments, and project teams.
Demonstrated capability to evaluate quality matters and solve problems using precedent and technical judgment.
Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
Proficiency in Root Cause Analysis (RCA), CAPA, and event investigations.
Operational QA experience in analytical or manufacturing settings (small molecule preferred; biologics, devices, and gene therapy experience a plus).
Practical GxP knowledge across the product lifecycle, including GMP regulations and application to manufacturing, RCA methodologies and tools, analytical techniques and data review, and risk-based decision making.
Effective communication across diverse audiences with strong relationship management skills.
Required Qualifications
Bachelor’s degree in a scientific or allied health field (or equivalent).
Minimum 4 years of relevant work experience, or an equivalent combination of education and experience.
Seniority level Mid-Senior level
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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