Operations Associate

Brooksource; Raleigh (NC); On-site; Full time

Job summary

An established industry player is seeking an Operations SAT Associate to enhance sterility assurance programs. This role is pivotal in driving operational excellence and compliance across various sites, ensuring robust processes and effective collaboration with cross-functional teams. You will lead efforts in harmonizing practices, resolving batch issues, and supporting new site start-ups. If you are passionate about improving operational capabilities and thrive in a dynamic environment, this opportunity is perfect for you. Join a team dedicated to excellence in pharmaceutical operations and make a significant impact on product quality and safety.

Qualifications

• Bachelor's degree in relevant field and 3-5 years of experience in biotech operations.
• Strong problem-solving and analytical skills with a focus on sterility assurance.

Responsibilities

• Drive harmonization of sterility assurance programs across the network.
• Collaborate with site teams to ensure compliance and operational readiness.

Skills

Problem-solving skills

Analytical skills

Knowledge of sterility assurance processes

Communication skills

Operational readiness

Mentoring and coaching

Regulatory knowledge

Education

Bachelor’s degree in Life Sciences

Bachelor’s degree in Engineering

Certifications in Sterility Assurance

Tools

Standard work documents

Process maps

Performance metrics

Job description

Job Title: Operations SAT (Sterility Assurance) Associate

Location: Raleigh, NC

Job Type: Contract to Hire

Job Description:

The Operations SAT Associate plays a critical role in supporting the implementation and continuous improvement of sterility assurance programs across our network. This individual will be an integral part of cross-functional teams, responsible for driving harmonization, providing technical support, and ensuring robust, compliant processes. Working closely with site leadership and experts, the Operations SAT Associate will contribute to achieving operational readiness, site performance, and compliance excellence, particularly in Parenteral Operations.

Key Responsibilities:

1. Leadership & Process Team Development: Act as a role model and drive behaviors that align with Manufacturing Standard Operating Environment (MSOE) standards. Lead efforts to improve capabilities and foster habits that support operational excellence.
2. Sterility Assurance Harmonization: Assess and identify differences between local sterility assurance programs across the network. Work to drive harmonization and ensure consistent processes that align with regulatory and compliance expectations.
3. Collaboration with Site and SMEs: Partner with site teams and cross-functional Subject Matter Experts (SMEs) to ensure control strategies are aligned and continuously improved. Foster alignment on sterility assurance practices across the organization.
4. Batch Issue Resolution: Identify and address batch-related challenges stemming from poorly designed or missing processes. Implement corrective actions to ensure right-first-time execution and minimize defects in production.
5. Standard Work and Documentation: Create and maintain standard work documents, process maps, and other tools aimed at ensuring right-first-time execution, operational sustainability, and continuous improvement.
6. Consulting on Best Practices: Provide consultation on best practices for critical processes such as work orders, deviations, change controls, and more. Mentor, coach, and provide feedback to teams to enhance their technical and operational capabilities.
7. Technical Support during Start-up: Offer technical support to new sites and filling lines during start-up activities, ensuring that sterility assurance programs and process/product requirements are met, especially during the early stages of site capability building.
8. Cross-Functional Communication & Influence: Serve as a conduit for communications between Production Teams (PTs), Functional Teams (FT), and Laboratories, ensuring alignment across departments and continuous information flow.
9. Inspection Readiness: Support preparation for self-led and/or agency inspections, ensuring all processes, documentation, and systems are in place and aligned with regulatory requirements.
10. Operational Readiness Implementation: Oversee all aspects of operational readiness, including shop floor readiness. Assist the site in implementing the necessary business support processes for routine production in the Parenteral area, from APS through ramp-up (approximately 9 months after PV).
11. Capability Building: Support the site in building the right capabilities for operations, particularly in Environmental Monitoring (EM) and Operations shifts. Ensure teams are trained and capable of handling the requirements for routine production.
12. Ramp-up Support: Provide guidance and support during the ramp-up phase, ensuring the right set of metrics are in place, reviewing line performance, and addressing human errors. Drive the prioritization of critical actions needed for successful production start-up.
13. Obstacle Removal: Collaborate with other teams and functions (e.g., Project Team, GPP) to identify and remove obstacles that may impede progress during the start-up and ramp-up phases of Parenteral Operations.
14. Liaison with RAMP/Acceleration Team: Act as the key liaison between the site and the RAMP/Acceleration team, coordinating planning and the allocation of support resources needed for operational success.
15. Environmental Monitoring Personnel Management: Manage and organize Environmental Monitoring (EM) personnel on duty, working closely with the production functions to ensure practices are consistent with procedures.
16. Performance Metrics: Oversee the preparation and tracking of the group’s performance measures, ensuring that all operational KPIs are met, and continuously look for opportunities for improvement.
17. Procedure Compliance: In collaboration with the EM Supervisor, ensure that practices on the shop floor align with established procedures, maintaining high standards of compliance and operational excellence.

Qualifications:

1. Education: Bachelor’s degree in Life Sciences, Engineering, or related field. Additional certifications in Sterility Assurance, Quality Control, or Operations Management are a plus.
2. Experience: Minimum of 3-5 years of experience in pharmaceutical or biotechnology operations, with a strong background in sterility assurance, environmental monitoring, or Parenteral operations. Experience in operational readiness, regulatory compliance, and manufacturing process improvement is highly preferred.
3. Skills:
1. Strong problem-solving and analytical skills, particularly in the identification and resolution of batch-related challenges.
2. Deep knowledge of sterility assurance processes and compliance standards.
3. Proficiency in creating and maintaining standard work documents, process maps, and performance metrics.
4. Excellent communication and cross-functional collaboration skills.
5. Experience in driving operational readiness and supporting the ramp-up of new manufacturing sites or production lines.
6. Ability to mentor, coach, and provide feedback to team members, building capabilities and improving performance.
7. Knowledge of regulatory requirements for pharmaceutical operations and quality control.

Job Type: Contract

Pay: From $32.00 per hour

Expected hours: 40 per week

Schedule:

1. 8 hour shift
2. Monday to Friday

Application Question(s):

1. What is your ideal pay rate per hour?
2. Are you currently located in Raleigh, NC?

Ability to Commute:

Raleigh, NC 27668 (Required)

Ability to Relocate:

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

Work Location: In person