About Kesin Pharma
Kesin Pharma is a rapidly growing pharmaceutical company specializing in the repackaging and distribution of prescription and OTC products. We are committed to operational excellence, regulatory compliance, and providing reliable, high-quality products to our partners.
Position Overview:
Ensure individual compliance with CFR 21 Part 210 & 211 FDA regulations, ICH Guidelines, cGMPs, and all other applicable requirements, applicable department programs to include training, documentation, standard operating procedures, and Kesin Pharma Corporation policies.
This is a 36 hour work week, weekend shift, 6:30am to 7:00pm, Friday through Sunday. There is a pay differential to make up for the 4 hours lost.
Key Responsibilities:
- Ensure compliance with all current "Good Manufacturing Practices (cGMPs), SOPs and facility safety standards as related to the equipment, work area and personnel.
- Assist Quality Assurance in-process personnel and functional processes.
- Responsible for reporting issues related to cleanliness, repairs and maintenance to Operations or Facilities Management and confirming quality approval before continued use of the affected area or item.
- Responsible for retaining and reserving sample management.
- Assists with the collection of stability samples or special request samples for each lot.
- Conducts daily verification of all Analytical Balances/Scales before use.
- Conducts start-ups and post clearance, as well as, hourly in-process room checks.
- Assists QA Associates in conducting internal and 3rd party external compliance audits.
- Conducts hourly in-process room checks.
- Ensures procedures are being followed daily.
Qualifications:
- High school diploma/GED.
- Able to stand, bend, and stoop for extended periods of time and ability to lift 45 lbs. unassisted.
- Previous experience in pharmaceutical GMP environment.
- Knowledge of FDA regulations related to GMP.
- Thorough knowledge of quality control/assurance and/or operations is preferred.
- Must have experience of pharmaceutical in-process stages.
- Must have a good interpersonal and communication skill in English, understand both oral and written instructions, and be detail oriented.
- General computer knowledge of basic software, i.e., Microsoft Word, Excel, email communication.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this role. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this position. Employees holding this position will be required to perform any other job-related duties as requested by management.
Location: Oldsmar, FL. The facility is in two neighboring buildings, and routine movement between buildings is required.
Department: Quality
Reports To: Quality Manager
Job Type: Full-time
Pay: $18.00 - $20.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Shift availability:
- Night Shift (Preferred)
- Overnight Shift (Preferred)
- Day Shift (Preferred)
Work Location: In person
