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Title:  GMP Specialist

Requisition ID:  42416
Date:  Nov 10, 2021
Location: 

Exton, Pennsylvania, US

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:  Support QA Manager and ALS Manager in ensuring QC and Analytical Laboratories operate in accordance with cGMP requirements. Ensure quality is maintained when there are issues arising from laboratories processes. Other activities include supporting quality improvement projects.

 

Essential Duties and Responsibilities:

  • Support QA Manager and Laboratory Manager in achieving and maintaining compliance with cGMP standards within the QC 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 and support on CAPA's
  • 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 QA Manager to maintain the ISO 15378 / 9001 system
  • Performs other duties as assigned based on business needs

 

Basic Qualifications: 

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

 

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 requirement and strong quality mindset
  • 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
  • Strong Experience in a GMP-regulated environment is desirable
  • Reliable, service-oriented, technical understanding, resilient and capable of working in a team
  • Careful and independent way of working
  • Effective communication and interpersonal skills
  • Good analytical and projects project management skills
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • 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 comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times

 

Travel Requirements:

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

Physical & Mental Requirements:

  • Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
  • Position operates in a professional office and lab environment. May stand or sit for extended periods of time
  • This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets
  • Read and interpret data, information, documents, analyze and solve problems
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Must maintain the ability to work well with others in a variety of situations

 

 

Competencies/Authorities

N/A
 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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