Quality Assurance

1 week ago

Gaithersburg, United States Miltenyi Biotec Inc Full time
Description

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.

Manager, Quality Assurance (Systems) Gaithersburg, MD

Your Tasks:

This position is primarily responsible for establishing and managing Bioindustry Quality Assurance system with respect to written Standard Operating Procedures, as well audits to ensure GMP manufacturing activities are compliant with regional, as well as internal requirements by performing the following duties.

Essential Duties and Responsibilities:

  • Develop and manage document control, product inventory management, final product release, training programs, data trending and metrics.
  • Manage the day-to-day Quality Assurance system to include writing, review and approval of Standard Operating Procedures and business practices.
  • Manage GMP training program, GMP subsystems such as Good Record Keeping practices and maintains training records.
  • Manage Quality Records program including archival facilities.
  • Manage Quality Event programs such as Deviations, Investigations, CAPA, Complaints, etc.
  • Review and approval of Quality Events such as OOL, OOS, CAPA, Investigation, etc.
  • Participate in a lead role in internal and external quality audits, including the timely preparation of audit reports.
  • Prepare/assess quality audit findings with respect to required corrective actions, ensure timely reporting to QA leadership and conducts follow-up.
  • Oversee the performance of designated staff, including interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
  • Coordinate and hosts client and regulatory authority inspections, as required.
  • Responsible for safety procedures and proper use of PPE.

Requirements:

  • Bachelor‘s Degree in the life sciences with four to six years‘ experience, master‘s degree in the life sciences with two to four years‘ experience; Experience in quality compliance review and document management a plus; Or a combination of education and experience.
  • Excellent oral and written communication.
  • Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products

Skills:

  • Demonstrated knowledge of Quality Assurance Database software, Project Management software, Spreadsheet software and Word Processing software.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.

These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body‘s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow. Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Every day presents a chance to make a tangible impact and play a key role in accelerating the journey of research from the lab to the market.

Join Miltenyi Biotec and immerse yourself in an environment where your efforts are significant, your contributions are valued, and your work truly matters.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.





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