- Perform and process in-process tests, perform other basic QA functions in raw materials, finished products and documentation when designated.
Duties (in Order of Importance)
• receive SOP training, perform in-process Quality Assurance duties in Production areas;
• substitute for second shift personnel as required;
• maintain file system (Ensur), issue request/review doc. /update doc. as required;
• maintain and update training records and SOPs;
• coordinate internal audits and cGMP training schedules;
• initiate and assist with material retest schedule;
• prepare discrepancy reports for expired/rejected raw material and finished products;
• perform incoming material/product inspection;
• handle stability study samples and retention samples;
• review completed batch production records before release;
• review quality control test reports of API materials, packaging materials for in-process and finished products before release;
• perform vendor qualification program and outsourced activity processes;
• follow up with deviation investigation reports and CAPA processes;
• prepare product quality review report on the parts related to their functions;
• create and revise SOPs;
• perform other duties as assigned.
Requirements for Special Knowledge, Skill and Ability
– English fluency and excellent communication skills
– Detail oriented
– Have positive and professional demeanor
Minimum Requirement for Education
– Bachelor’s degree or equivalent, or
– AA degree or equivalent, plus 1 year related industry experience.
At Carlsbad Tech, every eligible employee receives a competitive compensation package including Medical, Dental, Vision, Life Insurance, Short Term Disability, and Company match on 401K. Employees are also entitled to Paid Time Off, Sick Days, and Holidays.
To apply for this position, please send resume to email@example.com.