Lab Services Coordinator - Raw Material
- Job Title
- Lab Services Coordinator - Raw Material
- Job ID
- 27715369
- Location
- Lakewood, NJ 08701
- Other Location
- Description
-
Lab Services Coordinator - Raw Material
accupac is hiring for a full-time Lab Services Coordinator - Raw Material to join our 1st shift in Lakewood, NJ
Lab Services Coordinator - Raw Material Basic Job Functions:
The Supervisor position is responsible for managing all activities associated with the daily operation of the Quality Control analytical laboratory. This includes training, evaluating and directing laboratory staff, reviewing customer’s test methods, resolving technical problems, and prioritizing the laboratory schedule to meet the Manufacturing and Production timelines.
The Supervisor serves as a critical interface between the laboratory and other departments.
Essential Duties and Responsibilities include but are not limited to the following:- Assure that testing priorities are consistent with Manufacturing and Production schedules
- Review and approve final chromatographic data ensuring complete and properly documented results
- Follow up and communicate status of urgent items ,issues and schedule changes.
- Develop contingency plans to avoid missing schedule requirements.
- Assure adequate communication of priorities exists between the lab and other departments/sites, and within the lab from shift to shift
- Resolve problems with instruments , test methods, lab chemicals, standards, and samples.
- Maintain a thorough knowledge of GMP documentations and testing procedures
- Assure that all raw materials, bulks, and finished goods are tested in accordance with customer requirements
- Initiate the Out-of-Specification procedure. Assure test failures are investigated and documented, and that CA/Pas are employed
- Arrange installation and qualification of new instrumentation
- Evaluate new test methods. Coordinate implementation and training of new methods
- Interpret new/revised laboratory specification from customers and implement the specifications in Accupac’s documentation system
- Evaluate time and cost aspects of laboratory work associated with new products or new testing requirements
- Provide technical support to validation projects
- Assist in solving Manufacturing and Production problems
- Assure calibrations, standards, log books and other GMP compliant activities are performed in the laboratory
- Develop and implement ways to improve laboratory productivity, cost control and output
- Review and approve Material Assay Report masters/LIMS Configurations of products, SOPs, specifications, and other documentation as required
- Perform all other duties as assigned
Minimum Requirements of the Job:- Experience in GMP pharmaceutical product testing
- Experience in pharmaceutical Quality Control or R & D
- Understanding of USP testing methodology, analytical chemistry/instrumentation, particularly HPLC and GC
- Effective interpersonal, leadership and organizational skills
- Fluency in written and spoken English
- Ability to use computers for word processing and data manipulation
- Ability to manage multi-tasks and deal with several issues simultaneously, through prioritization, delegation, and “hands-on” personal effort in a fast paced, high volume environment
- Thorough understanding of laboratory safety requirements and the MSDS system
- Ability to read, comprehend, and interpret technical data, drawing and charts
Physical Requirements:- Sitting for 50% of the work day
- Walking/standing on concrete floors up to six hours each work day
- Hear/Execute clear speech, in person and over the telephone
- Bending/Stooping repeatedly
- Climbing step stools and maintaining balance
- Life/Carry items up to 40 pounds
- Pushing/Pulling items up to 75 pounds
- Hear phones ring, alarms sound through ambient noise and everyday conversation
- Possess color vision
Supervisory Responsibilities: Analytical Chemists
Travel: Minimal
Education and/or Experience: Bachelor’s Degree (B.S. or B.A.) in chemistry or closely related discipline with a curricula heavy in chemistry from a four-year college is required. Advanced degree in analytical chemistry is preferred and a minimum of five years of senior chemist-level, team leader, or management experience in pharmaceutical manufacturing, contract manufacturing or a combination of the two.
- Required Skills
-
Minimum Requirements of the Job:
• Experience in GMP pharmaceutical product testing
• Experience in pharmaceutical Quality Control or R & D
• Understanding of USP testing methodology, analytical
chemistry/instrumentation, particularly HPLC and GC
• Effective interpersonal, leadership and organizational skills
• Fluency in written and spoken English
• Ability to use computers for word processing and data
manipulation
• Ability to manage multi-tasks and deal with several issues
simultaneously, through prioritization, delegation, and “hands-on”
personal effort in a fast paced, high volume environment
• Thorough understanding of laboratory safety requirements and
the MSDS system
• Ability to read, comprehend, and interpret technical data,
drawing and charts