Deviation Writer - Osmotica Pharmaceuticals

Alora Pharmaceuticals, LLC.; Marietta (GA); On-site; USD 70,000 - 100,000; Full time

Job summary

Alora Pharmaceuticals, LLC. is seeking a qualified investigator to conduct formal deviations investigations in Manufacturing. The role involves initial and final impact risk assessments, root cause determination, and planning preventive actions.

You will track historical data trends and drive timely investigation closures across multiple departments. The ideal candidate holds a bachelor’s degree in a related science and 3–5 years in a cGMP setting with strong technical writing and communication

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmacy, or related field.
• 3–5 years in a cGMP manufacturing facility.
• 3–5 years in deviation/investigative writing or equivalent technical writing.
• Advanced writing skills essential.
• Strong critical thinking and deductive reasoning.
• Excellent written and verbal communication.
• Proficiency with MS Office; QA practices knowledge preferred.

Responsibilities

• Investigate deviations and write formal reports with site input.
• Perform initial and final impact risk assessments on processes.
• Lead root cause analysis and plan corrective actions.
• Track historical data trends and ensure timely closure.

Skills

Advanced writing

Critical thinking

Deductive reasoning

Interpersonal communication

MS Office

Education

Bachelor’s degree (Biology, Microbiology, Chemistry, Pharmacy)

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 probably root cause(s) and determine appropriate preventative and corrective actions.
• Trend and analyze product compliant investigation data and address appropriate as well 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