In an inter-departmental team environment, works to facilitate/incorporate effective quality practices for new and existing clients. Acts as the Primary Quality Assurance Representative for designated clients. Review and approval of GMP Certificates of Analysis (CoA’s), deviations, and CAPAs. Reviews, as necessary manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable. Monitor processes for adherence to
established procedures/regulatory compliance.
Responsibilities

• Review and approve Non-conforming events (NCE) and CAPAs.
• Pre-review/ approval of pre-executed batch records for assigned clients
• Post review of MFG batch records if required.
• Review / approval of MFG COA’s
• Perform timely review of complex study files, such as: Assay Validations, Process Validations
• Stay current with changes to GXP, including FDA and EU and other regulator bodies as well as guidance documents (ie: ICH, ISPE, etc.).
• Interact with MFG management to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management.
• Interact with project team to assure that project requirements and details are understood and effectively translated into MFG records.
• Interact with QA batch record reviewers to communicate project requirements and assure that details are adequately translated into MFG records.
• Work with document reviewers to compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
• Write and revise SOPs as necessary.
• Review and approve document change requests.
• Equipment Validation (IQ, OQ, PQ) and Change Control review/approval.
• Participate in quality and process improvement initiatives, and project teams.
• Coordinate execution of Manufacturing Suite inspections.
• Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections.
• Contact for on-site client visits. Participate/Lead to support internal and/or client audits
• Coordinate with Project teams in design, set up and execution of projects
• Review protocol and specifications for understanding and execution of orders.
• Facilitate and assure timely and accurate completion of pre and post executed batch records.
• 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
• Other duties as assigned
• May be required to assist in other departments

QualificationsExperience / Education:

• 4 years or more of relevant experience or equivalent
• BA/BS degree in a Science related major

Knowledge / Skills / Abilities:

• Scientific, Laboratory, and/or Production experience required. Extensive experience is highly preferable.
• Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required.
• Knowledge of EU cGMPs highly desirable.
• Knowledge of FDA PTC & MHRA Out-of-Specification guidance documents required.
• Knowledge of Root Cause analysis techniques required.
• Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable.
• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access).
• Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
• Ability to record data accurately and legibly.
• Ability to use judgment as dictated by the complexity of the situation.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication

Physical Requirements:

• 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
• Inside/outside working conditions