Auditor I (Mfg QA), Weekend Shift Days
Location: Salt Lake City Utah
Description: Teva Pharmaceuticals is currently interviewing Auditor I (Mfg QA), Weekend Shift Days right now, this vacancy will be placed in Utah. More complete informations about this vacancy opportunity please read the description below. Responsibilities:
Assist in the development, implementation and maintenance of quality assurance systems to ensure compliance with FDA, DEA an! d EPA regulations.
Perform routine production line checks efficiently and accurately.
Review line check documentation upon completion of lot.
Perform line clearance checks and verify completion of line clearance.
Perform Acceptable Quality Level (AQL) inspections.
Perform sampling of in-process and finished products using approved methods and SOP’s.
Inventory retain samples and perform regular inspections of retains.
Maintain logs as directed in SOP’s and by supervisor. Develop and maintain libraries of examples of defects for reference.
Perform training of new Associates as necessary
Assemble, collect, and manage all information necessary for the proper decisions on approval or rejection of all components, drug product containers, in-process materials, packaging materials, labeling, and drug products manufactured.
Assemble, collect, and manage the information necessary for the proper decisions on approval or rejection of procedur! es and methods impacting on the identity, strength, quality, p! urity and potency (ISQPP) of drug products.
Prepare initial draft and assist in review and approval of all standard operating procedures, test methods and specifications for raw materials, labeling materials, and packaging components.
Perform thorough review for approval of all new artwork and changes to existing artwork.
Assist in the review of production processes and records to assure quality; analyze trends.
Assure compliance to in-house specifications/standards and Good Manufacturing Practices. Maintain related documentation (eg, acceptance specifications, test methods, batch records).
Initiate and/or conduct investigations. May also serve as subject matter expert or QA2 role for investigations.
Ensure the company stays current of new developments related to good manufacturing practices and the quality functions.
Assist and/or take lead role in implementing all changes resulting from audit findings.
Perform the review of all lot testing ! results; ensuring adequate investigation, corrective action implementation, and follow-up where necessary.
Prepare all labeling components for use in production; Issue all labeling components to production.
Assist and conduct material evaluation and disposition.
Perform all work with an appropriate sense of urgency based on manufacturing and quality needs and with limited direct supervisory oversight.
Serve as a Quality contact for partner-related business.
Manage and lead various projects within the Manufacturing Quality functions.
Qualifications:
Requires a bachelor’s degree in a scientific discipline or equivalent with a minimum of 4 years quality, analytical, or manufacturing experience in a regulated industry.
Working knowledge of cGMP and GLP regulations required.
Working knowledge of DEA regulations and guidelines preferred.
The person who fills this position should possess good communication and mathematical! abilities. This position also requires a person who is detail-oriented! and precise with good writing and communication skills in order to complete daily duties and tasks. The individual will be involved in duties such as writing test protocols, participating in investigations of processes as necessary. The individual may also be involved in other quality related duties such as statistical process charting, trend analysis, and process capability. The individual will be expected to work independently and be punctual.
The individual must possess good judgement and decision-making skills in determining when a higher level of authority must be notified to resolve an issue. The individual must be able to perform in a fast-paced, multi-tasked environment. They must also be able to prioritize their workload. The individual must have the ability to ascertain problems while reviewing procedures/documentation.
- .
If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Teva Pharma! ceuticals.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Fri, 31 May 2013 20:46:38 GMT