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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
Quality Assurance Batch Release Specialist

Perform a timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release, including raw data, batch production records, and test results to confirm accuracy and completeness. Includes functions to move product through ERP system.  

Job duties include the review and/or approval of required documentation in a cGMP 503B outsourcing facility, ensuring compliance to regulations, policies, and procedures. Requires multi-departmental communication to quickly and effectively resolve batch record documentation related issues, to ensure finished goods are released in a timely manner. 

Candidate will be expected to manage multiple tasks and adjust priorities based on supply needs. 

Primary Responsibilities: 

  • Batch production record review and/or batch approval to include: 
  • Step by step documentation review for completeness/accuracy of batch records 
  • Verification of all audit logs 
  • Review of batch-associated Nonconformances and Quality Events for status prior to batch release 
  • Verification of all required documentation through ERP system 
  • Review of release specifications for conformance 
  • Identification and routing of paperwork for corrections in cases of missing or incorrect documentation  
  • Routing of batch records to Approval and/or routing of Approved batch records and product to proper location for distribution 
  • 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

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 
  • 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: 

  • Bachelor Degree in Science or Life Sciences preferred, or Associate Degree in Science or Life Sciences and a minimum of 6 months of related experience in a cGMP controlled/pharmaceutical industry. 

Preferred Qualifications: 

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

Job Type: Full-time
Pay:  $18.00 – $20.00 per hour

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355 Riverwalk Parkway
Tonawanda, NY 14150