Senior Manufacturing Associate
Site Name: Cambridge Binney Street
Posted Date: Mar 10 2023
Produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment. With limited supervision, responsibilities include but are not limited to having the ability to operate and perform process steps on equipment used within the manufacturing unit operations. Perform the weighing of manufacturing ingredients and the manufacturing of the intermediate formulations. Tasks include documentation, data entry, and computer software with compliant systems. Ability to perform continuous improvement actions toward safety and environmental inspections. Maintain continuous inventory control using computerized system. Must have the technical ability to interact with support groups such as facilities, process development, validations, etc., to ensure successful transfer of process changes. Must be willing and able to work in rotating shifts, extended periods, and/or overtime when required.
You will have the opportunity to…
Follow aseptic procedures and good documentation practices.
Follow production schedule to prepare and order required materials for production runs.
Prepare solutions per production schedule, as needed.
Cleaning, operating, and maintaining GMP equipment.
Prepare equipment for processing by performing cleaning-in-place (CIP) and cleaning-out-of-place (COP), as necessary.
Perform equipment inspections to ensure readiness and preventative maintenance, as needed.
Operate and monitor GMP equipment, adjust equipment controls, perform actions as specified by production batch records (BPRs), adhere to aseptic behaviors, and maintain a safe and clean work environment by following cGMPs.
Document production by completing forms, reports, logs, and records of equipment batches.
Maintain up-to-date training records.
Perform cleaning of production suites daily and as necessary.
Create and edit production records and documents, as necessary.
Work with environmental monitoring to maintain a clean and safe work environment.
Ability to lift up-to 20lbs.
Ability to troubleshoot and resolve process related issues and interact with support groups.
Ensure documents conform to cGMP standards.
Author deviations, CAPAs, and change controls as required.
Communicate with maintenance to ensure equipment calibrations, preventative maintenance, and non-routine work is coordinated.
Notify Management of safety issues and risks.
Provide technical training to junior employees.
Additional duties and responsibilities as required.
Who you are and what you bring to the team…
Associates degree in an area of life sciences with a minimum of 2 year of experience in manufacturing production or Bachelors’ degree in an area of life sciences with < 2 year of experience in manufacturing production required.
Effective oral and written communication skills required.
Experience or understanding of pharmaceutical development required.
Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations required.
Experience with leading and directing a team preferred.
Process organizational skills to ensure production batch completeness preferred.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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