Quality Control ChemistLewes, DE
As a team member of the Quality Control group, helps to ensure that the site follows all Federal, State and company mandated quality compliance programs with emphasis on proper current, Good Manufacturing Practices, (cGMP) documentation auditing and testing.
Essential Duties and Responsibilities
- Ensure site awareness of quality standard operating procedures (SOP’s) and (cGMP) regulations;
- Liaison with production as a representative for the quality program with special emphasis on proper (CGMP) documentation and auditing;
- Problem Resolution, method development, instrumental trouble shooting and validation;
- Perform good current good manufacturing procedures (cGMP) training to internal staff; testing process samples, raw materials, trial products and stability samples;
- Assist with Quality System audits as directed by the Quality Control, Supervisor;
- Provide a Quality presence in the production area while being the liaison with production employees for (cGMP) compliance; make recommendations for improvements;
- Create and/or approve labels after generation and other duties as assigned; maintain (cGMP) compliant documentation and data storage of testing performed.
- Review in-process batch record calculations in the absence of QA personnel;
- Conduct room and equipment inspections and approve release after production cleaning in the absence of QA personnel;
- Properly maintain and file controlled documents;
- Assist with deviation investigations that occur on-shift and drive closure;
- Uses Laboratory Information Management Systems (LIMS) to maintain testing results;
- Provide backup assistance to other Quality Control personnel as needed;
- Assist with collection of data for Regulatory Requests or Annual Product Reviews as applicable;
- Assist with customer compliant investigations as needed;
- Assist Quality Control Supervisor/Manager with tasks and projects as needed;
- Able to identify basic technical problems and develop solution ideas with the help of supervision;
- Ability to perform problem investigations with little to no supervision;
- Perform all other duties, as assigned.
Education, Skills and Experience
- Bachelor’s degree in Science field required
- Minimum 1 year of relevant and equivalent work experience within the pharmaceutical or chemistry industry.
- Experience with typical Quality projects such as (cGMP) documentation review/approval auditing, product and raw material release, change control, investigations, and training.
- Planning and organization: the ability to plan and manage multiple priorities and projects;
- Ability to work with all personnel in a professional and tactful manner;
- Attention to detail;
- Problem analysis and resolution;
- Excellent interpersonal and communication skills;
- Strong team player;
- Ability to act independently when handling recurring issues;
- The ability to learn and adapt quickly to new priorities and or situations;
- Meet project deadlines
- Displays technical commitment and initiative.
- Occasional travel may be required