Investigative Writer I

ABOUT US

Pine Pharmaceuticals is a family-owned and operated pharmaceutical company located in Tonawanda, NY along the beautiful Niagara River in the scenic Riverwalk business park. Our team is growing dramatically to meet the tremendous demand for sterile compounded drugs used by physicians every day across the country. Driven by teamwork, Pine is a prominent leader in the 503B outsourcing space, where we continue to innovate.

WHAT IT'S LIKE TO WORK HERE

Pine was founded on a culture of caring, and not just about the specialty coffees available on-campus! At Pine, our employees care about each other, about our community, and about the patient who will ultimately receive the drugs we are responsible for compounding every day. There are a lot of perks working for Pine, including regularly catered lunches, employee appreciation programs, generous discretionary bi-annual profit sharing, healthy work-life balance, and much more! Above all else, Pine Pharmaceuticals is a family-owned and operated company, and employees are treated just like that. Family!

Position Summary:
The Investigative Writer I will be responsible for the performance and authoring of investigations related to Quality Events identified during routine operations in a cGMP 503B Outsourcing Facility. The Writer will work collaboratively with the QA Compliance Supervisor and QA Compliance Specialist(s) responsible for investigative writing and investigation approvals.

Essential Functions:
• Timely and accurate execution of quality event investigations in accordance with internal policies and procedures, in compliance with required cGMP
• Gathering of information from internal and external sources including but not limited to personnel interviews, batch production reviews, analytical and manufacturing data analysis and trending, etc.
• Use of effective analysis tools to identify root cause for all investigations
• Performance of risk assessment and impact assessment of each quality event
• Identification and implementation of corrective and preventative actions (CAPAs) to minimize the impact of incidents and potential for repeat incidents
• Monitoring and analysis of investigation trends
• Facilitation of effective communication and collaboration between Production and Quality Teams
• Collaboration 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) pertaining to investigative writing and investigative approach
• Performance of other duties assigned by the Quality Management to ensure uniform quality assurance throughout the entire company

Education and Experience:
• 3-5 years of work experience in field subject to current Good Manufacturing Practices
• Experience in leading and writing event investigations, including root cause analysis and CAPA
• Experience in writing cGMP quality event investigations
• Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable

Knowledge, Skills and Abilities:
• Strong knowledge of cGMPs (FDA cGMP, CFR Parts 210 and 211, USP Chapters/Monographs) and experience in GMP processes and pharmaceutical document review to understand and guide process improvements.
• Understanding of quality systems and root cause analysis/risk assessments.
• Professional appearance, with excellent interpersonal communication skills including presentation skills, and multitasking 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.
• Ability to independently utilize critical thinking skills

Benefits:

• 401K with company match
• Discretionary bi-annual profit sharing
• Health insurance (eligible to enroll on first day of hire)
• Generous vacation/sick time
• Paid holidays
• Positive work/life balance
• Peer recognition program
• Leadership development
• Employee discount at our sister company, Pine Pharmacy

Smartphone access with the ability to down Microsoft Authenticator app