Sterility Assurance Technical Writer II
Company: WuXi AppTec
Posted on: September 17, 2023
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. Additional responsibilities
include ownership of change controls, laboratory protocols, and
providing a technical resource for topics around microbiology and
process improvements. Ensures that all equipment is properly
monitored by the EMS system were required.
- As author of investigations, gathers information from internal
and external sources in order to evaluate the impact of the
occurrence, risk to future processes, root cause analysis, CAPA
determination and effectiveness.
- Works cross-functionally in identifying opportunities for
continuous improvements documents appropriate
corrective/preventative actions designed to mitigate quality
- Works independently and with management to assure compliance
with procedural requirements.
- Demonstrates technical skills and solves complex problems.
- Responsible for working with internal teams to assure that
action items are investigated, monitored and tracked in an
electronic system ensuring that plans address root cause and tasks
are executed in a timely manner.
- Works on problems of diverse scope where analysis of data
requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques
for obtaining solutions.
- Works independently with minimal instruction.
- Normally receives minimal instructions on routine work and
detailed instructions on new assignments.
- Ability to work in a team environment and independently as
- Other duties as assigned.
- May be required to assist in other departments.
- May be required to work Holidays and weekends
- May be required to work Overtime
- May be required to work outside of normal business hours
- Contributes to the overall operations and to the achievement of
departmental goals Perform job specific tasks in compliance with
applicable Regulations, International Standards, and WuXi AppTec
Policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good
- Other duties as assigned
- May be required to assist in other departments
- 1-3 years of relevant experience or equivalent.
- Associates' degree with a major in a technical discipline or
- Excellent verbal and written skills
- Experience in investigation writing complex reports, studies
and/or scientific protocols.in a regulated environment, GMP, GDP,
- Ability to receive, comprehend and effectively communicate
detailed information both verbal and written.
- Ability to record data accurately and legibly
- Ability to work as part of a team and exhibit effective
- Uses professional concepts and applies company policies and
procedures to resolve routine and complex issues.
- Knowledge of cGMP requirements.
- Follows standard practices and procedures in analyzing
situations or data from which solutions can be readily obtained.---
Must be able to work in an office environment with minimal noise
- Must be able to work in Lab setting with Biohazards / various
- Must be able to wear appropriate PPE.
- Must be able to work in environment with variable noise
- Ability to stand / Sit / walk for long periods of time.
- Ability to crouch, bend, twist, and reach.
- Clarity of Vision.
- Must be able to perform activities with repetitive
- Ability to climb Ladders / Stairs / Scaffolding.
- Ability to work in variable temperatures high to freezing.
- Inside / outside working conditions.
Keywords: WuXi AppTec, Philadelphia , Sterility Assurance Technical Writer II, Engineering , Philadelphia, Pennsylvania
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