Career Opportunities

 

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Sterile Compounding Technician

Summary

Pine Pharmaceuticals Technicians shall be required to perform all necessary activities to provide the highest quality sterile drug products to our customers in a timely manner, including but not limited to the following:

 

Sterile Drug Preparation

  • Sterile drug preparation shall include but is not limited to:
    • The preparation of Batch Production Records
    • The completion of aseptic garbing and gowning
    • The compounding of sterile products
    • The cleaning and maintenance of aseptic compounding facilities
    • The labeling, packaging, and proper storage of completed products
  • Maintenance of his or her aseptic processing skills and shall demonstrate competency upon the completion of the training program, and every three months thereafter, as described in SOP 2400.
  • Read and follow all Pine Pharmaceuticals Standard Operating Procedures pertaining to sterile processing.
  • Equipment use and maintenance in the sterile compounding areas.
  • Use of environmental monitoring materials and equipment as outlined in SOP 1300.

 

Raw Material Intake and Evaluation

  • Receipt and inspection of Raw Materials as per SOP 3300.
  • Obtain Certificates of Analysis/Quality/Sterility when applicable.
  • Identification of any Raw Material that does not meet the quality requirements Pine Pharmaceuticals.
  • Storage of Raw Materials in proper locations/movement of raw materials through proper locations.

 

Order Fulfillment

  • Take in orders via telephone.
  • Fill orders using Approved product.
  • Pack and ship orders.
  • Shipping and receiving. May require use of box cutter.

 

Facility Maintenance

  • Clean aseptic compounding areas as necessary.
  • Clean non-sterile compounding areas as necessary.
  • Maintain clean and non-cluttered facilities.

 

Miscellaneous

  • Lifting up to 30 lbs may be required.

 

Job Type: Full-time

Great health benefits, 401k, generous vacation policy

QC Analyst

Summary

This QC analyst position will be located at Pine Pharmaceuticals, and will perform Quality Control testing to support cGMP manufacturing.

 

Responsibilities

This position is located within the Quality Control (QC) department and is responsible for daily laboratory operations and conducting routine and non-routine sampling and analysis via in house or facilitation with third parties for microbiology methods such as environmental monitoring, clean utilities monitoring, bioburden and endotoxin, and analytical methods including USP<788> particulate analysis in accordance with standard operating procedures (SOPs) in a cGMP compliant facility.

 

Job Scope

  • Provide support for laboratory activities such as preparation of laboratory reagents, material receipt, cleaning and autoclaving of materials/equipment.
  • Perform and track results for samples tested in house and via third party laboratories.
  • Maintain close communication and interaction with QC management and staff to ensure on-time testing of samples.
  • Perform a variety of microbial and analytical tests supporting manufacture of pharmaceuticals.
  • Will author reports, SOPs and other documentation for quality testing.
  • Provide training and technical leadership to less experienced staff.
  • Participate in laboratory investigations and non-conformance deviations.

 

Qualifications

  • BA or BS in science field with 3+ years working experience in pharmaceutical or biotech field.
  • Strong time management skills with attention to details and desire to achieve team and individual goals.
  • Be comfortable interacting with other team members within the group and other departments of the company.
  • Be able to handle multiple tasks in an organized and time-efficient manner.
  • cGMP and/or cGLP experience.

 

Additional Skills

  • Experience working with LIMS.
  • Experience with analytical methods including HPLC and USP compendial testing.
  • Knowledge of method transfers and qualifications.
  • Strong computer skills and working knowledge of general MS Office applications.
  • Demonstrate good communication skills, both written and verbal.
  • Be willing to work with a team to complete a job and proactively implement continual improvements.
  • Experience with microbiology methods such as bioburden, endotoxin, growth promotion.
  • Be comfortable working in a cleanroom environment.
  • Familiarity with maintenance of laboratory equipment.

 

Job Type: Full-time

Great health benefits, 401k, generous vacation policy


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