- To ensure that the QC Microbiological testing of all products is performed to GMP and company standards.
- This involves microbiological testing (as applicable), analyzing samples, recording, evaluating and reporting data using prescribed procedures with limited or no supervision.
location: Zebulon, North Carolina
job type: Contract
salary: $24.40 - 28.70 per hour
work hours: 9 to 5
- Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy and various instrumentation (e.g, HPLC, Vitek, GC, UV, microscope, gram stainer, robotics) while adhering to cGMP and established policy.
- Coordinate and participate in site projects, analytical/microbiological method development, validation, revision and transfer, and keep immediate supervisor informed of all important aspects of projects and assignments.
- Design and perform experiments to develop, validate, revise and transfer new analytical/microbiological methods including automated and robotic methods.
- Provide technical support and leadership as pertains to analytical/microbiological testing; verify that results are accurate and complete, recognizing deviations in test procedures, and/or SOPs.
- Appropriately document QCl data and investigations. Write laboratory documents such as technical reports, analytical/microbiological test methods, specifications, SOPs validation documents, and transfer documents.
- Train analysts in operation of equipment, analytical/test methodology, computer applications and safety procedures.
- Review and revise training materials.
- Identify training needs within staff.
- Participate in evaluation and selection of new instrumentation and assist with implementation.
- Provide technical support to group members, including integration techniques and calculations.
- Use technical expertise and skills to independently solve problems, including method and instrument troubleshooting.
- Release (approve/reject) analytical data from the laboratory for purposes such as manufacturing, product release to the commercial market.
- Demonstrate proficiency on most test methods within QC
- B.Sc. Degree or equivalent experience Area of Specialization* Chemistry/Biology or a related physical science Job-Related Experience
- Experience of providing QC testing support to at least one value stream.
- Developing knowledge and application of the Quality Management System (QMS)
- Knowledge of company products and quality impact as it relates to those products.
- Demonstrated ability to participate in product projects - command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations.
- Ensuring stability protocols are designed to be acceptable to regulators, maximize data generation and also utilize resources as efficiently as possible.
- Understanding of products, data and statistical tools to enable the construction of through life specifications and shelf-life specifications
- Experience working in teams to improve processes or resolve problems using OE tools.
- Operational knowledge of analytical chemistry/microbiology (as applicable), complex laboratory equipment, including ability to diagnose problems and identify appropriate actions.
- Full understanding of the requirements and application of GMP principles in a laboratory environment.
- Effective verbal and written communication on an individual and group basis targeted to appropriately audiences of several levels within GMS.
- Capability to assist with installation and validation of analytical equipment.
- Capability to assist with validation and transfer test methods as applicable.
- Developing leadership skills with an ability to form strong win/win partnerships.
- A demonstrated willingness to collaborate with colleagues to share best practices and /exchange ideas.
- Supports other teams when required.
- Technical expertise in a broad range of analytical methodologies from core HPLC techniques, sample preparation techniques (including automation) spectroscopy, dissolution testing, physical testing, hardness etc and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).
- Technical expertise in a broad range of microbiological methodologies from microbial challenges, identification, sample preparation techniques, facility monitoring/response etc and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.