GLQC - 2019
US ~ Boothwyn, PA
Group Leader (Quality Control)
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 Group Leader role is responsible for executing and managing testing, laboratory and personnel in the Quality Control department of the company.
Main duties and responsibilities include the following. Other duties may be assigned.
- Plan and execute work to meet deadlines. Ensure work is performed on time, correctly and in compliance with relevant requirements
- Provide technical guidance related to all project activities to the QC staff. Review and approve data and results. Oversee troubleshooting and investigations. Provide expertise to other groups as needed in performing investigations
- Author, review and approve reports, SOPs and protocols as needed
- Work closely with manufacturing and Quality Assurance departments to meet all Client and Quotient Sciences milestones
- Demonstrate scientific, technical and regulatory proficiency in the area of Quality Control Familiarity and expertise in compendial testing.
- Demonstrate sound judgment, goal oriented actions and work in collaboration with others
- Participate in discussions with clients and work closely with project management to provide Client and Project Management project progress and work plans
- Hire and retain the staff; develop and monitor performance and development plans for the staff
- Develop and implements training program for the department personnel
- Responsible for Quality of the work performed by the group
Other tasks and responsibilities will include:
- Assures laboratory runs in a safe, clean, and environmentally sound manner in addition to maintaining detailed records for FDA, DEA and safety and environmental purposes.
- Oversee/approve the procurement, installation, validation and calibration of new or existing laboratory instruments, equipment and supplies to ensure reliable, prompt, precise and accurate test data
- Assures that all work is performed in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Assures group complies with all company and site policies and procedures
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- providing opportunities for cross-training or additional growth opportunities for staff
- establishing an environment that fosters diversity and encourages teamwork
- Is available for other duties as required or assigned
- Supervise staff
- Requires B.S. in Chemistry, Pharmacy or equivalent with at least eight (8) years of industrial pharmaceutical laboratory experience, or M.S. in Chemistry, Pharmacy or equivalent with at least five (5) years of industrial pharmaceutical laboratory experience, or Ph. D. in Chemistry, Pharmacy or equivalent with at least two (2) years of industrial pharmaceutical laboratory hand-on experience; or a minimum of a B.S in Chemistry, Pharmacy or equivalent plus two (2) years of industrial pharmaceutical laboratory supervisor experience.
- Read, write and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedures
- Write reports and business correspondence
- Work with mathematical concepts such as probability and statistical inference
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions
- Define problems, collect data, establish facts and draw valid conclusions
- Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Other skills, abilities, and qualifications
- Expert knowledge of analytical chemistry and methods development
- Expert knowledge of chemical concepts and theories
- Familiarity with the production processes and unit operations.
- Proficient with a variety of laboratory equipment, such as GC, HPLC, KF, etc.
- 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 under stress in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment
- 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, crouch or crawl and taste or smell
- The employee must occasionally lift and/or move up to 10 pounds.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus
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.