Skip to main content

This job has expired

QA Specialist - MES - Fastest Growing Biotech Site in the E.U

Employer
NonStop Consulting
Location
Limerick
Salary
£40000 - £50000 per annum + Bonus + Relocation + Benefits
Closing date
Apr 12, 2019

View more

Sector
Science, Life Sciences, Cell and Molecular Biology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate

Job Details

With the fastest growing Biotech site in Europe (soon to be the largest as well) and a business model that has the company as one of the best employers in Europe and most financially successful as well, you will find yourself in an experience that will write history in the industry.

Summary: Performs activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and The Company's Standard Requirement Documents.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
* Train and/or mentor junior employees, including providing insights and education on processes and procedures;
* Provides consultation or advice in alignment with QA policies;
* Perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk
* Review, edit, or approve the company's controlled documents
* Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.
* Perform status labelling of raw materials and product
* Continually evaluating the company's processes and procedures with an eye toward continuous improvement
* Work directly with the MES and Operations teams in the design and development of electronic Master Batch Records and Equipment Specifications for site processes/products.
* Perform activities associated with the approval of design specifications, electronic Master Batch Records and MBR Testing.
* Perform the QA review and approval of the executed Electronic Batch Records to support product disposition.
* Review and approval of procedures associated with the Manufacturing Execution System.
Knowledge, skills, and abilities:
* Understanding of biologics manufacturing operations is preferred
* Good organizational skills and attention to detail
* Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
* Ability to handle multiple assignments and changing priorities.
* Ability to learn and utilize computerized systems for daily performance of tasks
* Ability to prioritize, manage multiple tasks, and meet deadlines
* Ability to stand for periods of time when performing tasks on the floor.
* Ability to work a varied schedule including off shift and weekends.


Experience And Required Skills :
Education and Experience:
* Requires BS/BA in scientific discipline or related field and minimum 2 year relevant experience.
* MS/MA in scientific discipline or related field
* Relevant experience may be substituted for education requirement.
* Experience with Manufacturing MES Systems advantageous.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert