QA Engineer, Drug Product - Second Shift

FUJIFILM Biotechnologies; Holly Springs (NC); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

FUJIFILM Biotechnologies in the United States is seeking a QA Operations Engineer to support second shift QA oversight for Drug Product Manufacturing. The role ensures GMP-compliant document control, change management, and quality system maintenance, with a progression to a 2-2-3, 12-hour rotating schedule.

Requires a Bachelors with 5 years (or Masters with 3 years) in a regulated GMP environment. Responsibilities span SME-level documentation, QA approvals, line clearance, deviation assessment,

Competenze

• Bachelor’s degree with 5 years of related experience, or Master’s with 3 years in a GMP setting.
• Experience in regulated drug product manufacturing is required.
• Strong documentation, change control, and QA oversight capabilities.

Mansioni

• Supports SME development of documents, processes and procedures for the Drug Product program.
• Generates, reviews and approves QA documentation and procedures for operational readiness and QA support.
• Provides shop floor QA support including line clearance, alarm response, and WO oversight.
• Ensures timely achievement of quality objectives and maintains validated state of systems.
• Oversees risk assessments, change management and lifecycle documentation.
• Participates in regulatory inspections and improvement initiatives.
• Performs other duties as assigned.

Conoscenze

QA Oversight

Document control

GMP experience

Cross-functional collaboration

Problem solving

Formazione

Bachelor's degree + 5 years related experience

Master's degree + 3 years related experience

Strumenti

Trackwise

Veeva

PAS-X

Smartsheet

Kneat

Descrizione del lavoro

This position supports a Monday-Friday 3pm-11:30pm shift schedule. In the future, this will shift to a 2/2/3 6am-6pm or 6pm-6am schedule.

The QA Operations Engineer is responsible to help drive the Quality oversight for Drug Product Manufacturing area and processes during second shift. This role collaborates within the DP Quality team as well as with other cross-functional teams. Ensures that all DP systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation.

What You’ll Do

• Performs an SME role within the QA team for the development of documents, processes, and procedures for the Drug Product program.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Manufacturing shop floor support, including AQL, critical process step verification, issue resolution, line clearance, alarm response, and work order (WO) oversight.
• Ensures project and operational quality objectives are met within desired timelines.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing systems are maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Performs other duties, as assigned.

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.
• 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.