US ~ Boothwyn, PA
Assistant GMP Coordinator
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
The Assistant GMP Coordinator will be responsible for assistance in the maintenance of the GMP area, equipment and related activities.
Other tasks and responsibilities will include:
- Ensure designated areas are in compliance and ready for client or agency audits as necessary
- Review SOPs related to the responsibilities.
- Assisting in the scheduling of routine cleaning activities for designated areas
- Assist in scheduling and oversight of equipment and designated areas cleaning as per cGMPs.
- Perform visual inspection of cleaned rooms and equipment to ensure proper cleanliness.
- Assist in coordination of cleaning verification activities.
- Assist in the coordination of equipment and facility repairs and routine maintenance and/or calibration activities.
- Assist in ensuring that all equipment are maintained in as per cGMPs
- Support Formulation/Manufacturing activities in order to maintain manufacturing timelines.
- Review of designated area logbooks routinely to ensure compliance.
- Work closely with QA to ensure that rooms and equipment are released quickly without delays.
- Maintain manufacturing supplies/spare parts inventory.
- Ensure quality and training of the group.
- Assist in any quality related investigations (such as deviations, discrepancies etc.) pertains to the designated areas.
- Participate in departmental meetings and contributes towards any improvement initiatives
The candidate should possess the following qualifications:
EDUCATION and/or EXPERIENCE
- High School Diploma or equivalent GED.
- At least 4-6 years of GMP area work experience preferred.
- Experience in review of GMP documentation and training of other personnel is essential.
- Knowledge of equipment handling and repairs
- Organizational skills
- Read and interpret documents such as safety rules, standard operating procedures, purchase orders, and packing slips.
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Successfully completes regulatory and job training requirements.
- Computer skills
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems
- Ability to perform repetitive tasks Ability to take appropriate actions in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment.
- Ability to work with little supervision
- Attention to detail
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.