OCM - 2019
US ~ Boothwyn, PA
Operator, Commercial Manufacturing
Our growing and successful business comprises of over 800 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 Commercial Manufacturing Operator is responsible for carrying out the manufacturing of commercial drug product while following all applicable SOP’s, Batch Records and maintaining a cGMP environment.
Main tasks and responsibilities
- Performs all tasks related to the manufacture of oral solid dosage drug products with supervision (i.e. dispensing, granulation, drying, milling, blending, compression, encapsulation and bulk packaging operations).
- Ability to read, execute and document master batch formulas and logbooks at the highest level of cGMP compliance with supervision.
- Perform physical in-process attributes on all products manufactured.
- Verify accuracy and calibration of all Equipment and in-process testing devices used in manufacturing processes.
- Set-up, operate, break down, clean and sanitize equipment and production rooms as per SOP’s, protocols and any provided trainings.
- Ability to troubleshoot equipment and perform any operational maintenance.
- Submit all In-Process or Release Samples to either Quality Control or Quality Assurance for testing or archiving as needed.
- Assure manufacturing department is neat and clean at all times and by end of shift.
- Participates in process and cleaning validation activities as required.
- Notify the GMP Coordinator or Manufacturing Housekeeper as needed to ensure supplies are kept in stock and not lapse.
- Obtain any Intermediates, Raw materials or Empty drums and ensure anything brought into the MFG Airlock(s) are wiped down and free of all contaminates.
- Responsible for maintaining the Tacky Mats outside of the assigned production suite at all times of the day.
- Inspect the assigned manufacturing suite, airlocks and equipment for any damage. Inform Supervisor and fill out work orders via online computer system as needed. Follow-up is required to maintain GMP’s. If work is not done in a timely fashion, communication and escalation to Production Supervisor or above is required.
- Reports any unsafe acts or conditions immediately to the Operations Management.
- Communicate any issues, compliance or concerns to the Production Supervisor and /or Quality Assurance.
- Ability to work Over-time may be required to meet production schedules.
- Perform additional functions and responsibilities as needed or assigned
- The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal business hours
- Needing to respond to client demands
- While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and talk or hear.
- The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, and crouch.
- The employee must occasionally lift and/or move up to 50 pounds.
- Must be able to qualify for respiratory protective equipment use.
Qualifications and experience required for competent performance
- High School Diploma required
- 2 - 5 years of pharmaceutical experience specifically with oral solid dosage.
- Experience in a cGMP environment
- Capable of Reading and Writing to a standard that aligns with GDP’s.
- Ability to interpret and carry-out instructions
- Computer literate, proficiency in a Windows environment.
- Ability to communicate effectively on a business/professional level.
- Maintains a Professional appearance, demeanor.
- Ability to work independently in a diverse and fast paced environment.
- Frequently checking and verifying in order to maintain cGMP Compliance through the company supplied training systems.
- Good decision making skills and ability to Multi-task.
- Fluent in English.
- Ability to Lift, Push or Pull 50 lbs. at a minimum
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.