Job Description
Description:
The Manufacturing Senior Associate (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Manufacturing Senior Associate will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:
Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing compliant documentation of all findings.
Clear and concise technical writing of major deviation investigations
Drive improvements to the investigation process
Present investigations to regulatory inspectors and internal auditors
Clearly communicate investigation progress to impacted areas and leadership
Coordinate and lead cross-functional teams through major deviations, and complete tasks on-schedule.
Project management of the investigations end to end
Build effective relationships across functions.
Navigate through ambiguity and provide a structured problem-solving approach.
Qualifications:
Bachelor's Degree in Science or Engineering and 3+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR * Associate's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
Technical understanding of fill/finish operations
Experience with compliance, problem-solving, root cause analysis, critical thinking, and quality systems.
Experience leading investigations/ deviations / non-conformances
Experience participating in and leading cross-functional teams
Experience in managing multiple, competing priorities in a fast-paced environment
Experience presenting to inspectors during regulatory inspections and internal audits.
Excellent technical writing
Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff
Ability to be flexible and manage change