QA Engineer, Drug Product - Second Shift

Knowledge, Skills, or Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to adapt in a fast-paced environment, pivot and adjust plans accordingly.
• Ability to think critically and have superior problem-solving skills, organization and planning skills.
• Team based attitude and ability to build relationships, and communicate effectively with others.
• Knowledge of Technology Transfer and/or Product Commercialization processes.
• High level of familiarity/understanding of hygienic utilities, quality systems, automation, manufacturing and IT systems, and validation of production equipment.
• Understanding of Data Integrity and application of 21 CFR Part 820 and Part 11.
• This role supports a 24/7 operations environment and requires working nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. Upon hire, the position will be assigned to second shift on a 5x8 schedule and is eligible for shift differential in accordance with Company policy. The role is expected to transition to a 2-2-3, 12-hour rotating schedule, with shift differential eligibility per policy. The timing of the transition will be communicated in advance and is subject to business needs.

Minimum Requirements

• Bachelor’s degree with 5 years of related experience; OR
• Master’s degree with 3 years of related experience.
• Experience working in a regulated GMP environment.

Preferred Requirements

• Understanding of formulation, aseptic filling and/or visual inspection.
• Working knowledge and experience with Trackwise, Veeva, PAS-X, Smartsheet and/or Kneat.
• Experience with startup projects.
• Training and/or familiarity with Quality Risk Management principles.