QA Shop Floor Specialist

Job Description:

Quality Systems support within Quality Operations, External Manufacturing. Ensure that Client. products manufactured at external contract manufacturers are manufactured, tested and released according to established Client specifications and the principles of Client directives. In addition ensure effective management of change controls, product quality complaints and CAPA.

Major duties and responsibilities:

Audit and disposition executed batch records pertaining to the preparation, formulation, granulation, final dosage form and packaging process of products manufactured at Third Party Manufacturing (TPM) sites.

When required compiles required disposition documentation (i.e. Contract Audits, FDA Import Documentation) needed for release of specific products. Maintains files for all lots of materials released by Quality Operations, Ext. Mfg.

Ensure product compliance with current specifications, procedures, validation requirements.

Alert management on trends noted during the evaluation of manufacturing documentation and verify with the TPM actions taken in order to restate control.

Input all necessary information into applicable enterprise-wide systems (Trackwise & SAP) related to third party manufactured products, e.g., lot disposition, product quality complaints, change controls, CAPA.

Document errors found during the auditing process and assure adequate corrections are documented.

Categorizes and reports documentation errors and deviations in order to notify management of trends and focus on the required corrective measures.

Provides input to management on the need of revision of manufacturing instructions based on trends, documentation errors or supplemented information.

Participate in Regulatory and Compliance audits FDA, DEA, EU, etc. as needed.

Exercise leadership, team skills, self-confidence, and effective decision making throughout projects.

Writes, reviews and implements procedures to assure update with current practices, audits or cGMP. Generates Certificate of Analysis, Certification of Conformance, Release Notifications and other release documentation as required by our customers or regional partners.

Participates in investigations related to the areas of supervision in order to monitor, measure and optimize or achieve the QA Department and Company goals.

Maintain extensive communication with TPMs and other Client groups such as Manufacturing Technology, Supply Chain, and Project Management Serves on Fact Finding or other project teams as assigned

Other duties as assigned by manager

Education:

B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.

Experience / Knowledge Desired:

A minimum of 3 years of experience in pharmaceutical Quality Control and/or Quality Assurance, with direct experience in drug product release and the use of Quality related enterprise-wide systems, i.e., Trackwise, LIMS (QCMain/Sample MangerO^) and SAP.

Experience in solid dosage forms and parenteral manufacturing desired.

Knowledge of compendial requirements, testing standards and specifications, regulatory filing documentation and cGMP, FDA regulations and the ability to interpret and apply them.

Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.

Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.

Must be able to correlate events and determine the action plan required to avoid incidents recurrence and or regulatory exposure.

Good verbal and written communication skills essential.

Excellent interpersonal skills at every level.

Capable to manage multiple priorities. #J-18808-Ljbffr