Deviation Investigation Writer Level 2
Location: This is an on-site position located in Pearland, TX.
The purpose of this role is to have responsibility for the initiation, investigation and completion of Minor and low/medium severity Major process deviations unassisted, and the supervised completion of high severity Major and Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence.
What you will get:
A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer:
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
What you will do:
Technical writing for the educated but uninformed reader, translating difficult and complex scientific events into a brief and cohesive report as a finished product.
Gathering Data from various sources across the site, lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact to SISQP, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing.
Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and resolution.
Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews.
Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
Complex Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty.
What we are looking for:
Ability to engage and interview co-workers to obtain relevant information pertaining to investigations.
Familiarity with cGMP quality systems.
Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).
Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint).
About Lonza:
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.