Specialist Manufacturing – Investigations

Amgen•Holly Springs, NC

6d•$107,545 - $145,503

About The Position

The Specialist Manufacturing – Investigations will be a key member of the team investigating major deviations at Amgen’s North Carolina Biologics Drug Substance Manufacturing plant. The role interfaces between GMP manufacturing teams and stakeholders including Process Development, Facilities & Engineering, Automation, EHSS, and Quality. It ensures deviation investigations are conducted and documented successfully while improving the investigation process.

Requirements

One of the following education and directly related experience combinations: doctorate degree; master’s degree and 3 years; bachelor’s degree and 5 years; associate degree and 10 years; or high school diploma/GED and 12 years.
Background in biologics drug substance manufacturing and investigations.
Strong cross-functional project management and communication skills.

Nice To Haves

5 or more years of related work experience in manufacturing, process development, or quality assurance in the biotech or pharmaceutical industry, with progressively increasing responsibility.
Experience with compliance, problem-solving, simple and complex root cause analysis tools (including 5 Whys, fishbone, Kepner Tregoe Problem Analysis®, and Design of Experiment), critical thinking, project management, and quality systems.
Degree in science or engineering.
Experience leading complex investigations.
Experience using Veeva QMS for deviation investigations and CAPAs.
Demonstrated project management ability.
Experience presenting to inspectors during regulatory inspections and internal audits.
Excellent written and verbal communication skills.
Ability to work in a team matrix environment and build relationships with partners.
Strong interpersonal skills.

Responsibilities

Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, developing CAPAs, and documenting findings compliantly.
Drive improvements to the investigation process.
Present investigations to regulatory inspectors, internal auditors, and management.
Communicate investigation progress clearly to impacted areas and leadership.
Coordinate and lead cross-functional teams through complex investigations and complete milestones on schedule.
Present complex topics to groups of different sizes and levels, and understand and communicate complex issues clearly.
Build effective relationships across functions.
Navigate ambiguity and provide a structured problem-solving approach.
Apply inductive and deductive reasoning to investigations.
Produce clear and concise technical writing.
Use Operational Learning Team strategies to promote open collaboration with staff and maximize investigation findings.
Develop tracking tools to support on-time closure and proactive review of deviation investigations.