US ~ Boothwyn, PA
Supervisor, Commercial Manufacturing (1st Shift)
Our growing and successful business comprises of over 900 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 Manufacturing Supervisor is responsible for ensuring the manufacturing of commercial drug product is carried out while following all applicable SOP's, Batch Records, Protocols and maintaining a stringent cGMP environment.
- To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- Manage performance of all manufacturing personnel by monitoring and directing daily activities, performance and training.
- Establish/maintain/exemplify a sense of urgency in completing daily activities.
- Motivate subordinates and involve them in the day-to-day operation and get their feedback.
- Work as a team and support counterparts.
- Make a goal to maintain weekly schedule compliance.
- Oversee the manufacturing process, including adhering to specified schedules, procedures and processes.
- Establish and uphold department standards.
- Supervise the manufacturing operation
- Verify that procedures and documentation are properly followed and submitted according to current cGMPs.
- Coordinate efforts with QA as required.
- Verify and sign that all records are correct and complete.
- Ensure that subordinates are properly trained.
- Perform a shift transfer, if necessary including a walking tour to discuss the status of each product on each piece of equipment.
- Ensure that all required information and materials are correct and available at the start of the shift.
- Communicate with and prepare for the subsequent shift.
- Enforce cGMPs, safety, and housekeeping and security procedures.
- Coordinate efforts with Maintenance Department to ensure equipment and manufacturing are running at optimum levels.
- Generate work orders for all equipment needing repair and including follow-up on status of repair once maintenance is contacted.
- Ensure that SOPs, training and cGMPs are current and followed by manufacturing personnel, maintaining appropriate records.
- Discuss any safety issues/concerns.
- Communicate any issues, compliance or concerns to the Manager of Commercial Manufacturing and /or Quality Assurance.
- Notify manager when adequate coverage is not possible.
- Batch records are to be reviewed in a timely manner and delivered to QA.
- Be responsible for actions of the technicians.
- Be aware of where operators are and what products and processes, they are running.
- Oversee other tasks and responsibilities as assigned.
- Ability to work over-time may be required to meet production schedules.
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 working hours
- Needing to respond to client demands
- High School Diploma required; College preferred
- 10+ years of pharmaceutical experience specifically with oral solid dosage.
- Experience in a Pharmaceutical 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, demeanour.
- Ability to work independently in a diverse and fast paced environment.
- Frequently checking and verifying in order to maintain cGMP Compliance both personally and for manufacturing employees through the various company supplied training systems.
- Good decision-making skills and ability to Multi-task.
- Fluent in English.
- Ability to Push, Pull or Lift up to 50 lbs.
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.