Quality Assurance Specialist - Internal Auditor

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Quality Assurance Specialist - Internal Auditor

Gaithersburg, MD

Tasks:

As a Quality Assurance Specialist - Internal Auditor, you will be responsible for performing Internal Audit activities for the site. You will perform inspections of departments, processes, or practices to assure the auditee is meeting site, company, and regulatory requirements. Additionally, you will prepare, perform, close-out, and monitor internal audits and associate CAPAs. As a result of your ability to assist in the inspection readiness of the site, you support the continued success of Miltenyi Biotec as a whole.

Among other responsibilities, you will:

• Lead and support Quality aspects of the Inspection Readiness program, including participate and lead internal audits, participate in client and regulatory audits, and assess regulatory guidance and updates.
• Communicate with departments regularly to address any concerns, improve performance, and foster an environment that facilitates continual improvement in working relationships.
• Perform periodic facility walkthroughs to identify compliance risks before audits or inspections
• Execute remote and onsite audits.
• Create, Maintain, and distribute reports related to quality to upper management including identifying, reporting, and escalating relevant Quality issues to management.
• Ensure CAPAs (internal, client, regulatory) are performed per defined Quality / Business Corporate and Site Objectives / KPIs and Metrics.
• Establish standards, processes, procedures to provide compliance with regulatory requirements and Quality Standards for site activities.
• Drive Compliance Lean Initiatives Author / write and review SOPs / documentation.
• Train New Hires, as applicable.
• Compile and provide Compliance Quality Metrics on a monthly, quarterly and annual basis.

• Conduct supplier audits on a regular basis to ensure suppliers and their supplies remain in compliance with company and federal manufacturing and production standards.
• Communicate with suppliers regularly to address any concerns, improve performance, and foster an environment that facilitates continual improvement in working relationships.
• Performs investigation and analysis of supplier complaints and notification of changes.
• Supports new product development projects.
• Experience in GMP-regulated industries in Manufacturing Operations, Process Validation with Quality Systems knowledge.
• Understand and interpret regulations and standards (i.e, including 21 CFR part 11, 58, 210/211, 606, ISO 9001, 13485 and 17025 and EU industry standards).
• Support review and disposition of incoming materials, and material qualification as required.

Requirements:

• Bachelor’s Degree in Scientific / Biotech / Pharmaceutical field of study or combination education, experience, and knowledge; 2-5 years of biopharmaceutical industry experience in Quality Assurance or Regulatory Affairs or an Associate’s Degree with 4-7 years’ experience in Quality Assurance; or an equivalent amount of education an experience.
• Experience in cGMP, API drug development, Auditing and Inspection Management, and Global Regulatory Requirements preferred .
• Previous internal audit experience (2-3 years with Lead Auditor experience) and knowledge of US and International cGMP regulations is required.
• Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

COMPUTER SKILLS:

To perform this job successfully, an individual should have knowledge of Master Control, Excel spreadsheet software, and MS Word Processing software. PowerPoint and Visio knowledge is a plus.

OTHER SKILLS:

• Demonstrated ability to manage multiple projects and excellent organization skills. Demonstrated ability to prioritize work, to act and work independently, and to report items as required to Senior Management. Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
• Show strong negotiation skills and diplomacy in communication with internal customers.
• Knowledgeable of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations.

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. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have the 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.

Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as core strength of our company. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus, we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.

Lentigen Technology, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity