QC Operations Technician

Job Title: QC Operations Technician

Job Location: Raleigh, NC

Job Type: Contract to Hire

Job Description:

We are seeking a highly motivated and experienced QC Operations Technician to join our dynamic team. This role offers an opportunity to work at the forefront of operational excellence within a Parenteral operations environment, ensuring compliance, quality, and the efficient functioning of our manufacturing processes. As a key player in the Quality Control team, you will support critical activities across production, environmental monitoring, and operations readiness, helping drive continuous improvement and ensure successful operational ramp-up.

Key Responsibilities:
Process Team Leadership & MSOE Adherence: Serve as a role model in driving MSOE standards and behaviors within the process team, ensuring habits that contribute to high performance and continuous improvement.
Batch Issue Identification & Resolution: Identify and troubleshoot batch-related challenges that may arise from gaps in process design or execution. Implement corrective actions to ensure quality and operational consistency.
Documentation and Tools Creation: Develop, maintain, and implement standard work documents, process maps, and other tools that ensure right-first-time execution and long-term sustainability.
Consultation on Best Practices: Advise and provide guidance on best practices related to work orders, deviations, change controls, and other critical processes. Mentor, coach, and provide feedback to employees in the manufacturing and operations teams.
Cross-Functional Influence & Communication: Exhibit influence across teams and serve as a conduit for communication between process teams, functional teams, and laboratories to ensure seamless operations and knowledge sharing.
Inspection Readiness Support: Prepare the team for self-led or agency inspections, ensuring operational processes and documentation are fully prepared and aligned with regulatory standards.
Operational Readiness Oversight: Support the preparation of the site for operational readiness, ensuring smooth transition from APS to routine production for the Parenteral area. Assist in the implementation of business support processes needed for successful ramp-up.
Capability Building: Work with site leadership to build the right capabilities in operations teams, including EM shift, Ops shift, and process teams, ensuring all are trained and aligned for successful operations.
Ramp-Up Support & Metrics: Provide support during ramp-up, including setting the right metrics, reviewing line performance, and addressing human errors on shifts. Drive the prioritization of critical actions for the start-up of Parenteral Operations.
Obstacle Removal: Collaborate with other teams and functions (e.g., Project team, GPP) to identify and remove obstacles that may impede site progress and operations.
Planning & Escalation: Serve as the point of contact for site functions and project teams for planning, alignment, and escalation of issues that may arise.
Liaison Between Sites & RAMP/Acceleration Teams: Act as the key liaison between the site and the RAMP/Acceleration team, coordinating support resources and ensuring alignment on operational objectives.
Environmental Monitoring & Personnel Management: Oversee the management and organization of environmental monitoring personnel, working closely with production functions. Ensure practices align with procedures, maintaining quality control and operational standards.
Technical Support & Oversight: Provide Environmental Monitoring (EM), utilities, or microbiological testing technical and quality support to laboratory and plant-site personnel. Offer guidance on methods, assist in routine and investigational data collection, and support troubleshooting of technical issues.
Coaching & Benchmarking: Provide coaching on environmental monitoring, utilities, sterility assurance, microbiological testing, and equipment qualifications. Assist teams in benchmarking best practices and ensuring consistent, high-quality outputs.

Qualifications:
Education: Bachelor's degree in Life Sciences, Engineering, or related field. Certifications in Quality Control, Environmental Monitoring, or Operations Management are preferred.
Experience: A minimum of 2-4 years of experience in pharmaceutical or biotechnology operations, with experience in quality control, process improvement, and operational readiness. Experience in Parenteral operations or similar environments is highly desirable.
Skills:
Strong problem-solving and troubleshooting skills, particularly in addressing batch-related issues and process inefficiencies.
Ability to create and maintain standard work documents, process maps, and tools.
Proven experience with operational readiness, inspection preparation, and ramp-up processes.
Experience in environmental monitoring, microbiological testing, or utilities operations.
Strong communication and interpersonal skills for cross-functional collaboration.
Ability to mentor and coach teams in a fast-paced, high-performance environment.
Knowledge of regulatory standards and industry best practices.

Job Type: Contract

Pay: From $32.00 per hour

Expected hours: 40 per week

Schedule:
8 hour shift
Monday to Friday

Application Question(s):
What would your ideal hourly pay rate be?

Ability to Commute:
Raleigh, NC 27668 (Required)

Ability to Relocate:
Raleigh, NC 27668: Relocate before starting work (Required)

Work Location: In person