Deviation Writer - Osmotica Pharmaceuticals

Alora Pharmaceuticals, LLC.; Marietta (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Alora Pharmaceuticals, LLC. is seeking a investigator to conduct formal investigations of process deviations in a cGMP manufacturing environment.

You will assist in risk assessments and root cause analysis, and plan corrective and preventative actions while tracking historical data and ensuring timely closure. The role requires strong writing, critical thinking, and excellent communication skills, with a focus on QA practices.

Qualifications

• Bachelor’s degree in a science field; CGMP experience preferred.
• 3–5 years in a cGMP facility.
• 3–5 years of deviation/investigative writing experience or equivalent.
• Advanced writing skills.
• Strong critical thinking and deductive reasoning.

Responsibilities

• Perform risk assessments of deviations and complaints impacting product and patient safety.
• Gather information from internal and external sources to evaluate impact on past products and future operations.
• Lead investigations across Manufacturing, Packing and other departments to ensure timely closure.
• Identify probable root causes and determine preventive and corrective actions.
• Trend investigation data and liaise with production and quality.
• Follow procedures for deviation and complaint investigations.
• Conduct interviews with site personnel for deviation reports.
• Lead root cause problem-solving sessions.

Skills

Advanced writing

Critical thinking

Interpersonal communication

QA practices awareness

Education

Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmacy or similar

Tools

MS Office

Job description

Position Overview

Conduct and write formal investigation of process deviations for Manufacturing with the assistance of site personnel. This position will also perform initial and final impact risk assessment as well as assist in root cause determination and plan appropriate corrective action and preventative action. The incumbent will also assist in the tracking and trending of historical data and assure timely closure.

Duties and Responsibilities

• Ensure compliance with relevant SOP’s while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process and patient health and safety.
• As part of the investigation, gather information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufacturing product, as well as the risk to future operations.
• Leads and support investigations across Manufacturing, Packing and other departments to ensure timely closure for each investigation and follow-up activities.
• Works with the functional areas to identify the most probable root cause(s) and determine appropriate preventative and corrective actions.
• Trend and analyze product compliant investigation data and address appropriate as well as liaison with production and quality.
• Work independently to comply with procedure driven guidelines relating to deviation and complaint investigations.
• Conduct interviews with site personnel to gather data for the deviation report.
• Perform as the lead in root cause problem-solving sessions.

Experience and Qualifications

• Bachelor’s degree (Biology, Microbiology, Chemistry, Pharmacy or similar)
• 3-5 years related experience in a cGMP facility
• 3-5 years of deviation, investigative writer experience or equivalent technical writing experience
• Advanced writing skills
• Strong critical thinking and deductive reasoning skills
• Excellent interpersonal and communication (written and verbal) skills
• Strong MS Office skills
• Understanding of QA practices and standards is preferred