STASKA Pharmaceutical Careers

• Plan, manage and coordinate the development, implementation and maintenance of quality assurance systems.
• Ensure compliance of company operations to quality principles and cGMP requirements.
• Develop & implement appropriate corrective and preventive action plans to prevent or correct deficiencies.
• Develop and implement quality systems including drafting/implementing SOPs and managing training of scientific & production teams on laboratory, QC and analytical procedures.
• Act as subject matter lead in FDA inspections, audits and other Quality Assurance tasks.
• Review and approve qualification and validation protocols and plans for clean-rooms, systems, and process activities associated with the manufacturing of sterile products in aseptic environments.
• Direct the development and implementation of validation test procedures to ensure products meet validation requirements. 

Bachelor’s degree in Chemistry or Pharmaceutical Sciences is required, plus five years’ work experience as Quality Control Manager or Related Occupation is required.

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The aseptic technician will prepare, mix, and assemble finished sterile products with a focus on patient safety and quality. This tech ensures that the clean room maintains constant cleanliness and all standard operating procedures are followed with 100% accuracy and documented thoroughly.

Responsibilities Include:

• Maintains a sterile environment in the cleanroom, with garbing, cleaning, and working according to CGMP practices or guidelines.
• Clean the equipment in the clean room daily and ensures equipment validations are up to date.
• Takes inventory in the clean room to identify components needed to fill production batches, as scheduled.
• Ensures all components entering the clean room are sterile.
• Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products; communicates within the clean room, from room to room.
• Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs.
• Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers.
• Validates that garbing standards have been followed on a semi-annual basis.
• Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months.
• Follows standard operation procedures to package sterile products in their final container closure.
• Uses appropriate process to establish sterility on products received from and entering the clean room compounding area.

Qualifications:

• High school diploma or equivalent.
• Previous experience in a hospital IV room or manufacturing environment or doing aseptic filling.
• Knowledge of clean room procedures, required.
• Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations, preferred but not required.
• Must pass aseptic technique validation three consecutive times before working in the cleanroom.
• Ability to work with others in a positive and professional manger with teamwork.
• Ability to take initiative and will work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Ability to prioritize and plan each days work load. Manages time effectively and adapts quickly to changing priorities.
• Ability to handle multiple tasks and organize resources to ensure work is completed on time.

Job Type: Full-time

Salary: $15.00 to $20.00 /hour

Education:
High school or equivalent (Preferred)

Language:
english (Required)

Application Question:
Are you familiar with cGMP?

Work Location:
One location

Benefits:
Health insurance
Paid time off

This Job Is:
A job for which military experienced candidates are encouraged to apply
A job for which all ages, including older job seekers, are encouraged to apply
Open to applicants who do not have a college diploma

Schedule:
Monday to Friday
No weekends
Day shift

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