- WuXi AppTec
- $105,360.00 -158,170.00/year*
1103 Market St
This position is responsible for Sterility Assurance and Environmental Operations across all three Philadelphia sites. This includes: development/optimization of current processes and programs to ensure compliance with regulatory requirements, training and evaluating personnel, organization development, and making appropriate decisions and recommendations to address trends, issues or significant observations.
Formulates strategies for routine monitoring and microbiology testing, performance qualifications, prepares protocols and standard operating procedures (SOPs), and reviews and approves work of subordinates. Conducts, schedules, and directs monitoring and testing activities, keeping appropriate records consistent with regulatory guidance, business needs and client expectations. Gathers and collates results of environmental testing, identifies trends, interprets implications, and recommends procedural changes to drive improvement. Communicates with Management, clients, auditors and others as appropriate. Participates in development and implementation of validation plans and protocols. Effectively assists with client and regulatory audits/inspections as appropriate.
* Directs, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's standards.
* Oversees the initiation, prepares and revises new protocols, SOPs, Deviations, Investigations and other technical documents as directed by management.
* Interacts with pertinent internal departments (e.g. Manufacturing, Quality Assurance and Quality Control) to assure that appropriate testing information is effectively communicated.
* Demonstrates leadership and support of company goals and objectives.
* Directs activities associated with Environmental Monitoring Process Qualifications for new facilities, existing facilities, as well as to both US and EU requirements.
* Responsible for gathering, collating, interpreting and reporting environmental testing results, and for making sound recommendations based on the results.
* Demonstrates independent scientific technical expertise and programmatic leadership.
* Effectively interacts with clients and/or regulators to address scientific and related issues.
* Interacts with subcontractors (as appropriate) and assumes responsibility to ensure timely and accurate completion of all subcontracted work.
* Maintains full compliance for areas of responsibility with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
* Maintains accurate records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs. Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
* Plans, monitors, and appraises direct reports including performance competencies, goals & job results
* Coaches, counsels, and conducts disciplinary actions
* Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
* Ability to work in a team environment and independently as required
* Maybe required to work Holidays and weekends
* 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 Manufacturing Practices
* Performs other duties as assigned
* 10 or more years of relevant experience or equivalent
* Bachelors' degree in Microbiology or similar science related field or equivalent experience
* Knowledge of cGMP guidelines is required.
* Experience with EMPQ Execution and Best Practices, APV (Aseptic Process Validation), Media Fill Qualifications, and FDA exposure.
* Knowledge and experience in sampling and testing air (e.g., settling plates, RCS), water, surfaces (contact plates, swab samples), solutions, chemicals, materials, and personnel microbial contamination.
* Knowledge of monitoring and testing manufacturing utilities, including air (e.g., Met-One particle counter), water (sampling for USP tests) and clean steam for quality and non-biological contaminants.
* Knowledge of sampling and testing to support studies of cleaning and sterilization efficiency. Ability to direct both biological and non-biological testing of environmental samples, and to critically assess and communicate the implications of the testing results.
* Sufficient breadth and experience to appropriately interpret testing results, making sound recommendations and decisions.
* Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
* Ability to evaluate technical data and write technical documents.
* Must be able to work in an office environment with minimal noise conditions.
* Must be able to work in Lab setting with Biohazards /various Chemicals
* Must be able to wear appropriate PPE
* Must be able to work in environment with variable noise levels
* Ability to stand /Sit/walk for long periods of time
* Clarity of Vision
* Ability to identify and distinguish colors
* Must be able to perform activities with repetitive motions
* Ability to climb Ladders / Stairs / Scaffolding
* Ability to work in variable temperatures high to freezing
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
Associated topics: administrative, administrative coordinator, asso, associate, chief operations officer, facilities, front office, food, operation, operational support
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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