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363626 BURGWEDEL BIOTECH GMBH

Associate Specialist External Laboratory QC(m/w/x)

Burgwedel
Full-timeWith Home OfficeExperienced

In this 12-month role, you will bridge the gap between internal quality teams and external labs, ensuring all analytical data meets strict standards while managing complex investigations.

Requirements

  • Degree in Life Sciences, Chemistry, Biotechnology, Pharmacy, or related discipline
  • Experience in GMP-regulated pharmaceutical or biotechnology environment
  • Experience with external laboratory management and oversight
  • Understanding of analytical testing by third-party laboratories
  • Experience with deviation management, CAPA, and change control
  • Desirable experience supporting batch release using external data
  • Experience with SAP and electronic Quality Management Systems
  • Proficiency in English and German
  • Detail-oriented and accountable work approach

Tasks

  • Act as the primary QC contact for external laboratories
  • Ensure compliance with cGMP and quality standards
  • Provide technical oversight for analytical testing and methods
  • Manage external laboratory investigations like OOS and OOT
  • Review and trend analytical data using ALCOA+ principles
  • Track laboratory performance through KPIs and quality metrics
  • Support audits and regulatory inspections for contract labs

Work Experience

approx. 1 - 4 years

Education

Bachelor's degree

Languages

EnglishBusiness FluentGermanBusiness Fluent

Tools & Technologies

SAPelectronic Quality Management SystemsLaboratory Information Management System (LIMS)

Benefits

Flexible Working

  • Flexible working hours
  • Hybrid working model

Retirement Plans

  • Attractive company pension scheme

Additional Allowances

  • 13 monthly salaries

Bonuses & Incentives

  • Target bonus

More Vacation Days

  • 30 days holiday entitlement

Career Advancement

  • Internal training and promotion

Other Benefits

  • International co-operations
  • Medicinal product development insights
  • Working across borders

Learning & Development

  • Training on the job

Purpose-Driven Work

  • Process design contribution

Corporate Discounts

  • Corporate benefits

Parking & Commuter Benefits

  • Free car parking

Generous Parental Leave

  • Paid Parental Time Off
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