Danaher Jobs

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Job Summary

The primary function of this role is to provide Quality and compliance leadership and direct supervision for in-process reviews of manufacturing, packaging, labeling, laboratory operations, technical services, storage, distribution, and quality systems at Aldevron. This individual will support and execute company directives, policies, processes, and procedures in support of this objective. Additionally, the OQA Supervisor will help resolve any quality issues on areas of oversight that impact manufacturing delays and successfully address complex problems or development and implementation of robust preventative or corrective actions to enhance overall operational reviews.

Job Responsibilities

• Manage the daily activities of the OQA Specialists and OQA Leads

• Train, develop, and mentor a team of OQA professionals

• Provides ‘on-the-floor’ Quality oversight of manufacturing, inspection, packaging, labeling, warehousing, and provides timely input to enable compliant and timely operations

• Serves as the Subject Matter Expert (SME) in assessing the impact of excursions and deviations that occur during operations

• Assists the relevant functional group in driving to true root cause during process investigations

• Performs “real time” batch record review on the floor to reduce or eliminate errors and improve Right First Time (RFT)

• Supports a program to ensure timely batch record review, resolution of batch-related investigations and review of laboratory test results, to enable a smooth release of finished product

• Review, revise and approve batch production documents for release by confirming that all specification have been met, all quality events have ben comprehensively investigate and closed, and all applicable testing has been completed with confirmed passing results.

• Collaborate with internal partners in other parts of Quality Assurance (QA), Quality Control (QC), Technical Operations, and Supply Chain to resolve issues

• Proactively seek opportunities to improve Quality processes in efforts to further improve compliance and create efficiencies

• Represent OQA team during meetings and Kaizen events

• Provide technical input and justification for release or rejection of OQA reviews

• Manages reviewed and in-process documentation necessary for in-process releases including solution preparations, in-process QC testing and SOPs

• Participates in any issues that require management escalations

Qualifications

• 3+ years of relevant experience in a quality position, required

• 2+ years of that experience in a lead, supervisory or managerial position

• Direct experience with regulatory or internal audits and inspections

• Bachelor of Science preferred.

• Life science related field preferred or equivalent experience.

• 5% travel

Additional Skills

• Experience in process understanding as it pertains to cGMP manufacturing

• Comprehensive understanding of cGMP manufacturing expectations

• Exposure to regulatory agency inspections or other types of audits (e.g. FDA, notified bodies, ISO, etc.).

#LI-LCS

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.