Deviation Investigator Jobs

Collaborating with cross-functional teams and participating in daily management meetings

Utilizing your experience with Investigation/Deviation and Biotech, preferably in MFG/QC

Previous experience with investigation/deviation in a Biotech environment (MFG/QC)

Strong communication and collaboration skills

Ability to work on-site in Houston, TX (remote work not available for this role)

Initiating and conducting thorough investigations to identify root causes

Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.

Able to effectively multi-task and execute project management skills.

Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.

Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.

Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.

Proposes solutions for complex issues and works with management to resolve.

· Collaborating with manufacturing and laboratory management to ensure compliance with global regulatory requirements.

· Knowledge of cGMP requirements in the United States and globally.

· Verifying that the site stability program aligns with global and regulatory requirements.

· Minimum of 3 years of experience in the pharmaceutical or a related industry.

· Strong writing skills and the ability to thoroughly review investigations, interpret findings, and draw technical conclusions.

Quality Assurance – Deviation Reviewer

Must have strong knowledge and experience with cGMP, GCP, GLP Quality, and Compliance.

Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.

Proposes solutions for complex issues and works with management to resolve.

Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.

Excellent verbal and written communication skills.

Advanced knowledge of complete MS Office suite. Firm understanding of technology platforms as needed for project.