Senior Quality Associate

Jobtailor; Deutschland; Remote; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a quality assurance professional to support the Quality Management System within a FDA-regulated biotechnology environment.

You will author and review SOPs, assist in vendor management, and contribute to continuous improvement while ensuring regulatory compliance and thorough documentation. Travel may be required for vendor audits and cross-functional collaborations.

Qualifikationen

• 4+ years of full-time cGMP Quality Assurance experience.
• Experience with eQMS (ACE, TrackWise).
• Working knowledge of FDA-regulated biotechnology environments.
• Excellent record keeping and documentation skills.
• Strong verbal and written communication skills.
• Proficient use of MS Office products.

Aufgaben

• Support implementation, maintenance, and improvement of the Quality Management System.
• Support CDMO and CTL management.
• Author and review Standard Operating Procedures (SOPs).
• Provide Quality Onboarding training.
• Support vendor management activities.
• Review and approve vendor documentation.
• Review executed manufacturing records in support of product disposition.
• Support computer system validation activities.
• Support quality performance and continuous improvement activities.
• Assist in compiling metrics for Quality Management Review.
• Perform other duties as assigned.

Kenntnisse

CGMP QA

Vendor management

SOP authoring

Documentation skills

Quality metrics

Regulatory knowledge

Strong communication

MS Office

Ausbildung

Bachelor's degree in Biology, Chemistry or related field

Tools

eQMS (ACE, TrackWise)

MS Office

Jobbeschreibung

• Support implementation, maintenance, and improvement of the Quality Management System
• Support Contract Development and Manufacturing Organization (CDMO) and Contract Testing Lab (CTL) management
• Author and review Standard Operating Procedures (SOPs)
• Provide Quality Onboarding training
• Support vendor management activities
• Review and approve vendor documentation
• Review executed manufacturing records in support of product disposition
• Support computer system validation activities
• Support quality performance and continuous improvement activities
• Assist in compiling metrics for Quality Management Review
• Perform other duties as assigned

Requirements

• Bachelor's degree in Biology, Chemistry or other relevant scientific discipline preferred
• 4+ years of full-time cGMP Quality Assurance experience
• Travel required up to 35%
• Experience with eQMS (e.g., ACE, TrackWise)
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
• Excellent record keeping and documentation skills
• Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings
• Experience working with CDMOs preferred
• Proficient use of MS Office products
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Ability to work effectively both independently and with other team members

Core Competencies

Demonstrates expertise in Quality Management Systems, cGMP Quality Assurance, and vendor management within FDA-regulated environments. Proficient in authoring SOPs, conducting quality training, and supporting continuous improvement initiatives.

Highest-signal resume keywords

• CGMP Quality Assurance Experience
• EQMS Experience
• Standard Operating Procedures (SOPs) Authoring
• Vendor Management
• Quality Management System Support

Hard Skills

• Quality Management System
• CGMP
• Standard Operating Procedures (SOPs)
• Quality Metrics Compilation
• Computer System Validation
• Documentation Skills
• Quality Onboarding Training
• Manufacturing Record Review
• Regulatory Compliance
• Biology or Chemistry Degree

Soft Skills

• Strong Communication Skills
• Adaptability
• Team Collaboration
• Flexibility
• Sense of Urgency

Industry Keywords

• FDA-Regulated
• Biotechnology
• Contract Development and Manufacturing Organization (CDMO)
• Contract Testing Lab (CTL)
• Quality Performance Improvement

Tools & Technologies

• EQMS (ACE, TrackWise)
• MS Office