STASKA Pharmaceutical Careers

Staska Pharmaceuticals is a FDA registered 503B outsourcing facility located just outside Lincoln, NE. Staska Pharmaceuticals is a trusted outsourcing facility that provides customized pharmaceuticals to surgery centers, hospitals and medical offices in Nebraska and surrounding areas. Staska is dedicated to providing sterile and non-sterile products with patient safety and uncompromised quality as our top priorities.
 

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Quality Director

STASKA Pharmaceuticals, an FDA-registered Human Drug Compounding Outsourcing Facility (503B), is seeking a Quality Assurance Manager to manage and coordinate QA efforts in its sterile manufacturing facility near Lincoln, NE. This role will be responsible for developing, implementing, monitoring and maintaining STASKA’s quality program, procedures, policies and strategies and ensuring company compliance to cGMP regulations and internal procedures that are intended to comply with regulations governing sterile pharmaceutical products. The QA Manager will oversee cleanroom and sterile manufacturing compliance to include: Regulatory Interactions, Lot Release, Validations, Training, Materials Management, Documentation Control, Batch Record Development, Review and Control, Root Cause Investigations, CAPA, OOS, Regulatory Submissions and other compliance needs for the company.  This position will be subject matter lead for quality assurance and regulatory/cGMP compliance issues within the company.  

Position responsibilities: 

  • Oversees the development, implementation, and maintenance of quality assurance systems and activities including but not limited to document control, commissioning/validation, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review/lot release 
  • Participation in the development of quality systems through SOP writing and training
  • Creates appropriate corrective and preventive action plans to prevent or correct deficiencies 
  • Acts as subject matter lead in FDA inspections, audits and other QA tasks 
  • Responsible for ensuring compliance of company operations to quality principles and cGMP requirements
  • Responsible for performing inspections, checks, tests, and sampling procedures of incoming ingredients, component and consumed material used in the manufacture and packaging of STASKA products
  • Coordinates and ensures that cleanrooms, their equipment, materials, layout and documentation meet good manufacturing practices 
  • Responsible for training employees within and outside of the department to assure up-to-date knowledge of practices and procedures of Quality Assurance 
  • Oversees and approves qualification and validation protocols and plans for cleanrooms, and systems, cleaning, and process activities associated with the manufacturing of sterile products in aseptic environments 
  • Coordinates and ensures training on validation equipment and materials and documentation requirements in good manufacturing practices 
  • Directs the development and implementation of validation test procedures to ensure products meet validation requirements 

Profile:

  • Bachelor’s degree in life science, engineering or other related discipline 
  • 5 to 7 years of experience with QA in a cGMP, FDA regulated manufacturing environment 
  • 5+ years in aseptic, sterile based drug manufacturing/compounding environment with strong cleanroom and contamination knowledge.
  • Multidisciplined experience in various functional areas of the pharmaceutical manufacturing industry, such as regulatory affairs, Quality Assurance, Quality Control, validation, computer systems validation, etc. is preferred.
  • Effective written and oral communication skills, including strong editorial skills for the review and approval of cGMP documentation, including protocols, reports, SOPs, etc
  • Experience with FDA site inspections is required 
  • Quality orientation and high attention to detail
  • Demonstrated ability in leading teams and outside vendors to get results through others 
  • Strong working knowledge of cGMP regulations, USP standards, and ICH and FDA guidance documents
  • Ability to make decisions and recommendations 
  • Prior experience with the QA component of design and build of cleanrooms is preferred

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Aseptic Technician

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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