Manufacturing Compliance Associate

Manufacturing Compliance Associate at Lumen Bioscience

Lumen Bioscience is seeking a detail-oriented Manufacturing Compliance Associate to support our GMP operations and ensure compliance within our pharmaceutical manufacturing environment. This role involves conducting thorough investigations of manufacturing deviations, identifying root causes, and implementing effective corrective and preventive actions (CAPAs). If you have a passion for quality, strong technical writing skills, and enjoy collaborating across teams, we encourage you to apply.

Role Description:

• GMP Manufacturing Support: Provide on-the-floor (OTF) support for GMP activities, including facility walkthroughs, management of deviations, quality event handling, assessments, investigations, CAPAs, and record review.
• Documentation and Records: Author and review essential GMP documentation including Standard Operating Procedures (SOPs), Work Order Records (WORs), Forms (FORs), and On-the-Job Training materials (OJTs).
• Investigations and CAPAs: Conduct thorough investigations into manufacturing deviations through data collection, staff interviews, and documentation reviews to accurately identify root causes and develop effective CAPAs.
• Team Collaboration: Work closely with manufacturing operations, Quality, and supporting teams to implement procedures, programs, and training to enhance operational efficiency and compliance.

Essential Duties and Responsibilities:

• Support and actively participate in GMP manufacturing activities and facility walkthroughs to ensure ongoing compliance.
• Conduct investigations into deviations and quality events, accurately documenting findings and resolutions.
• Author, review, and maintain critical GMP documentation and training materials.
• Gather and analyze data through process observation and staff interviews in production areas.
• Regularly update investigation status, escalate issues when necessary, and maintain clear communication across teams.
• Ensure strict compliance with cGMP, safety policies, and established company procedures.

Qualifications & Requirements:

• Educational Background: Associate or Bachelor's degree in a relevant scientific discipline preferred.
• Professional Experience: 1-2 years' experience in GMP-regulated environments, specifically involving authoring documents, batch record reviews, deviations, investigations, and root cause analysis.
• Technical Knowledge: Familiarity with cGMP, ISO 9001, and ICH guidelines for quality records and document control required.
• Technical Skills: Strong technical writing skills; proficiency in Microsoft Office Suite (Word, Excel, PowerPoint); experience with quality management systems is highly preferred.
• Personal Attributes: Detail-oriented, highly organized, proactive, with the ability to manage multiple tasks simultaneously in a fast-paced environment. Strong interpersonal skills and commitment to quality and ethical standards.

Physical Requirements:

• Ability to sit and stand for extended periods (2 hours).
• Occasionally lift or carry items up to 20 kg.

Salary & Benefits at Lumen Bioscience:

• $65,000-$70,000 annually annual stock bonus
• Health, Dental, and Vision premiums fully covered by Lumen.
• 401k match up to 4% in addition to annual stock bonus for all employees.
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure.
• Monthly wellness program to support your health and well-being.
• Free onsite parking or public transportation subsidies.
• Comprehensive parental leave policies.
• Life insurance, short & long-term disability, and access to employee assistance programs.

At Lumen Bioscience, we foster a workplace that encourages innovation, collaboration, and professional growth. This role offers an opportunity to enhance your compliance expertise while contributing significantly to advancements in biotechnology and global health solutions.

Join us and play a crucial role in ensuring manufacturing compliance and quality excellence.

Salary : $65,000 - $70,000