West Pharma GMP Support Specialist 

United States, North Carolina 

393666720

Job Summary:

Support QA and Site Laboratory in ensuring QA and Site Laboratory operate in accordance with cGMP requirements. Ensure quality is maintained when there are issues arising from QA or laboratories processes. Other activities include supporting quality systems reviews and analysis, and QA improvement projects.

Essential Duties and Responsibilities:

• Support QA and Laboratory in achieving and maintaining compliance with cGMP standards within the QA and Analytical laboratories.
• Ensure that the documentation in QC and Analytical laboratories follows cGMP standards and support the Laboratories in the administration of documentation and electronic systems.
• Provide support with regards to cGMP compliance during projects such as method validation, method transfer, instrument qualification and verification of Compendia Test Methods.
• Provide functional expertise and advice for proper
  • calibration of analytical instruments
  • verification of Excel Spreadsheets
  • set-up of computerized systems
  • etc.
• Perform periodical review and audit data of laboratory test results, computerized systems, Excel Spreadsheets, laboratory notebooks, electronic raw data, etc to ensure cGMP compliance.
• Guide internal and external audit of QC and Laboratory
• Support CAPA's related to quality systems and laboratory systems
• Oversee the proper administration/completion of cGMP processes in laboratory such as on time review of Laboratory procedures, guide
• Train QC and Laboratory staff in GMP relevant topics
• Work with global team to drive Data Integrity initiatives.
• Prepare reports timely to highlight QA monthly and quarterly statistics.
• Support maintenance of the ISO 15378 / 9001 system.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Any other duties as assigned by direct supervisor, QA Manager, and Laboratory manager.

Basic Qualifications:

• Successfully completed training as a chemistry or biology laboratory assistant or as a chemical-technical or biological-technical assistant (m / f / d).
• Work experience in a comparable position.
• Experience in a GMP-regulated environment.
• Able to always comply with the company’s safety policy
  • Highlight unsafe practices to responsible persons
  • Proper use of Personal Protective Equipment (PPE)
  • Work safely by not causing unsafe conditions or doing unsafe acts
• Able to always comply with the company’s quality policy.
  • Work in accordance to the local and global procedures
  • Compliance to GMP requirement
• Able to be aware of all relevant SOPs and Company policy as they relate to the position covered by this Job Description

Preferred Knowledge, Skills and Abilities:

• Fluency in English required
• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards
• Good knowledge of cGMP requirements
• Quality mindset
• Effective communication and interpersonal skills
• Good analytical and projects project management skills

Travel Requirements:

• Must be able to travel up to 5 % of the time.

Physical & Mental Requirements:

• Must follow and comply with Plant’s Dress and Hygiene Code (SOI)
• Regularly uses hands and fingers to operate objects, tools or controls. Frequently required to stand, talk and hear for long periods of time.
• Reliable, service-oriented, technical understanding, resilient and capable of working in a team.
• Careful and able to be self-directed.

Educational Requirements:

• Bachelor's in scientific discipline preferred.
• Experience: 3-5 years of experience in quality assurance in a Pharmaceutical or Medical Devices manufacturing environment