Sterility Assurance Technical Writer I

WuXi AppTec - Philadelphia, PA

Full-time

Philadelphia, PA

Ambulatory Health Care Services

About the position

This position is responsible for investigative writing, performing root cause analysis, developing appropriate corrective and preventative action for deviations, developing protocols for qualification of sterility levels, and periodic reporting for microbiology and sterility assurance. The role requires ownership of change controls, laboratory protocols, and providing a technical resource for topics around microbiology and process improvements. It is essential to ensure that all equipment is properly monitored by the EMS system where required. As the author of investigations, the individual will gather information from internal and external sources to evaluate the impact of occurrences, assess risks to future processes, conduct root cause analysis, and determine corrective and preventative actions (CAPA) and their effectiveness. The position involves working cross-functionally to identify opportunities for continuous improvement and documenting appropriate corrective/preventative actions designed to mitigate quality deficiencies. The candidate will work independently and with management to assure compliance with procedural requirements, demonstrating technical skills and solving complex problems. The responsibilities also include collaborating with internal teams to ensure that action items are investigated, monitored, and tracked in an electronic system, ensuring that plans address root causes and tasks are executed in a timely manner. The role requires working on problems of diverse scope where analysis of data requires evaluation of identifiable factors, demonstrating good judgment in selecting methods and techniques for obtaining solutions. The candidate must be able to work in a team environment and independently as required, and may be required to assist in other departments. The position may also require working holidays, weekends, overtime, and outside of normal business hours. The individual will contribute to the overall operations and achievement of departmental goals while performing job-specific tasks in compliance with applicable regulations, international standards, and WuXi AppTec policies and standard operating procedures. A thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) is essential.

Responsibilities

• Gather information from internal and external sources to evaluate the impact of occurrences and risks to future processes.
• Conduct root cause analysis and determine corrective and preventative actions (CAPA) and their effectiveness.
• Work cross-functionally to identify opportunities for continuous improvement and document corrective/preventative actions.
• Assure compliance with procedural requirements while demonstrating technical skills and solving complex problems.
• Collaborate with internal teams to ensure action items are investigated, monitored, and tracked in an electronic system.
• Work on diverse problems requiring evaluation of identifiable factors and demonstrate good judgment in selecting methods for solutions.
• Work independently with minimal instruction and as part of a team as required.
• Assist in other departments as needed and contribute to departmental goals.

Requirements

• 1-3 years of relevant experience or equivalent.
• Associates' degree with a major in a technical discipline or equivalent experience.
• Excellent verbal and written communication skills.
• Experience in investigation writing, complex reports, studies, and/or scientific protocols in a regulated environment (GMP, GDP, 21CFR210 & 211).
• Ability to receive, comprehend, and effectively communicate detailed information both verbally and in writing.
• Ability to record data accurately and legibly.
• Ability to work as part of a team and exhibit effective interpersonal skills.
• Knowledge of cGMP requirements and standard practices for analyzing situations or data.

Nice-to-haves

• Experience in laboratory settings with biohazards and various chemicals.
• Familiarity with Good Laboratory Practices (GLP).

Benefits

• Opportunities for internal growth and development.
• Access to a dedicated and accessible Human Resources team.