KEY RESPONSIBILITIES.

• Review of batch production records (including analytical test packages, cleaning records, etc.): The incumbent’s primary responsibility will be to ensure that batches meet GMP requirements and are manufactured according to approved Standard Operating Procedures (SOP), and appropriate resolution to batches pending approval due to GMP errors and related corrective action investigations. Review in-process batch records, finished product batch records and intermediate analytical records. Release intermediate products, based upon conformance with specifications and completion of associated documents.

• Operations Support: Actively walk the production areas to promote and ensure current Good Manufacturing Practices are being adhered to. In real time address any corrections or deviations with production staff explaining the impact and how to avoid the error moving forward. Review all batch related data generated by the Production team in real time during the shift, including but not limited to executed batch records, temperature recordings, cleaning records, In-process checks, equipment status tags and logbooks for accuracy, completeness and compliance to data integrity.

• Administrative Duties: Support QA administrative duties such as; issuing master production records and appropriate labeling to manufacturing, ensuring that the current version is issued. File completed batch production records, testing records, and cleaning records. Support maintenance of document tracking systems.

• Audits: Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during an audit. Conduct internal audits and housekeeping inspections and walkthrough’s of site Quality Systems and related operations to ensure compliance with written procedures. Audits quality system and records, creating documentation as needed. Follow-up as appropriate to ensure corrective action is implemented. During an audit of ASH, participate in the audit to explain ASH’s quality systems and operations. The incumbent is expected to represent ASH’s systems thoroughly and positively,

being receptive to the auditor’s comments. Participate in the development of a formal response to audit report

as appropriate.

• Reports/Document Management: This may include support to Annual Product Reviews, Non-Conforming

Material Reports, and Investigation Reports. Participate in preparation or review of associated documentation,

such as Analytical Methods Validation Reports, Cleaning Validation Reports, and Process Validation Reports.

• Quality Systems Support: Ensure compliance with internal approved procedures of all generated data.

Participate in the implementation of continuous initiatives as they relate to production and quality activities.

Provide data and information pertaining to operations or systems for internal or external clients as requested.

Identify trends from batches that are associated with deviations/corrections and present corrective actions in

order to reduce the number of deviations/corrections. Assist in effective implementation of data integrity

procedures and overall data integrity compliance in Production. Perform other related assignments and

projects as required.

• Metrics: Perform routine and adhoc Quality Systems Metric Reporting and analysis for the local site data.

Prepare metrics and perform trend analysis in support of management review.

• Risk Management: Participate in the Risk Management program, including updating risk analysis, participating

in applicable teams and maintaining Risk Management documents.

EDUCATION/EXPERIENCE.

• Bachelor’s degree in the physical or biological sciences or engineering with 1 or more years’ experience in

pharmaceutical operations/quality or another GMP environment.

• Associate’s degree with 2 or more years’ experience in pharmaceutical operations, regulated life sciences, or

quality assurance.

• Individuals without a degree but having at least 3-5 years’ experience in pharmaceutical operations, regulated

life sciences, quality assurance, or an equivalent combination of Quality and technical education will also be

considered.

• Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).

• Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and

statistical tools.

• Proficient in TrackWise, SAP and Master Control or experience working with document management and ERP

systems.

JOB COMPETENCIES.

• Excellent organizational and planning skills.

• Strong written, verbal, and interpersonal communication skills.

• Strong attention to detail orientation.

• Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.

• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.

• Experience interacting with FDA or other regulatory agencies

• Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, SPC,

etc.)

• Must complete tasks independently and notify supervisor of decisions outside of established processes