Careers

If you are hard-working and service-oriented, we want you. Check back often for opportunities to join our growing team.

Current openings

Aseptic Operator

Job Description & Responsibilities

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. Maintain understanding of all updates to all SOPs.
    • Equipment use and maintenance in the sterile compounding areas.
    • Use of environmental monitoring materials and equipment as outlined in SOP 1300.
  • Facility Maintenance
    • Clean aseptic compounding areas as necessary.
    • Clean non-sterile compounding areas as necessary.
    • Maintain clean and non-cluttered facilities.
  • Physical Requirements:
    • At times, continuous repetitive motion of hands/wrists
      • Gripping, capping, filling syringes
Production Support

Job Description & Responsibilities

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:

  • Finished Drug Packaging
    • Visually inspect, label, package, and ensure proper storage of completed products according to cGMP.
    • Utilize and understand proper aseptic gowning and garbing procedures as per applicable SOP.
    • Read and follow all Pine Pharmaceuticals Standard Operating Procedures pertaining to job function. Maintain understanding of all updates to all SOPs.
    • Properly utilize all equipment and perform necessary maintenance activities as needed.
    • Ensure product appearance meets all required specifications.
    • Train as needed for new products.
  • Facility Maintenance
    • Clean aseptic compounding areas as necessary.
    • Clean non-sterile compounding areas as necessary.
    • Maintain clean and non-cluttered facilities.
  • Cross-Training Responsibilities
    • Perform training in distribution center operations.
    • Demonstrate understanding of order fulfillment and shipping operations.
    • Perform training in order processing operations.
    • Perform distribution center activities and order processing activities based on the needs and requirements of daily work flow.
MQA Batch Release Document Reviewer

Perform all document review associated with finished products, including raw data, batch production records, and test results to confirm accuracy and completeness; perform functions through ERP system.

Primary Responsibilities:

  • Batch production record review to include:
  • Step by step documentation review for completeness/accuracy of batch records
  • Verification of all audit logs
  • Verification of all required documentation through ERP
  • Identification and routing of paperwork for corrections in cases of missing or incorrect documentation
  • Triage workflow to ensure first in-first out release of finished product according to distribution needs.
  • Work collaboratively with company Regulatory Affairs personnel to ensure current understanding of all rules and regulations from applicable regulatory boards and committees (example: State Board of Pharmacy, FDA, USP guidelines and OSHA)
  • Work collaboratively with the production department to ensure quality and compounding policies and procedures are kept current
  • Perform other duties assigned by the MQA Manager to ensure uniform quality assurance throughout the entire company

Knowledge Skills and Abilities:

  • Knowledge of laws and regulations regarding cGMP Human Drug Compounding
  • possess a professional appearance, with excellent interpersonal communication skills including presentation skills, and multitask ability
  • Strong computer skills, knowledgeable with standard Microsoft Office suite, email, document scanning, and strong Excel and Word experience
  • Self-motivated and organized with minimum supervision
  • Full knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and various State Board of pharmacy laws as they relate to the Human Drug Compounding.

Required Qualifications:

  • A minimum of 3-5 years Quality Assurance / Quality Control experience
  • A minimum of Bachelor’s degree
  • Full knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and various State Board of pharmacy laws as they relate to the Human Drug Compounding

Preferred Qualifications:

  • Strong preference given to candidates with Pharmaceutical QA / QC experience

 

Job Type: Full-time

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355 Riverwalk Parkway
Tonawanda, NY 14150