Overview
Specialist Pharmaceutical Quality Systems Jobs in Mount Vernon, IN at AstraZeneca
Assure the consistent quality of all manufactured products by:
Being responsible for food safety and quality
Understanding all government regulations; staying up-to-date on government regulations by subscribing to FDA website, reading journals, and attending meetings and seminars
Understanding the quality requirements of customers and management to insure that production meets these standards
Extending product quality documentation system by updating procedures and training the QA & Safety Manager, who will document the procedures
Assuring the compliance of federal, state and local legal requirements, anticipating new legislation, enforcing adherence to requirements, and advising COO on needed actions
Maintaining professional and technical knowledge by attending educational workshops, especially those on label law and nutritional analysis, reviewing professional publications, and establishing personal networks
Manage and train QA staff. Work closely with the QA & Safety Manager in his performance of the responsibilities detailed below:
Maintain raw material standards by studying manufacturing requirements, working with Purchasing to understand purchasing process, and establishing testing procedures for incoming raw materials
Oversee process product inspection standards by helping to document existing procedures and devising new quantitative methods of product evaluation
Assure proper disposition of finished product by building on the existing standards
Assure rework standards by following written guidelines for rework and training personnel on how to follow them
Coordinate an effort to produce a label spec book and assure that correct label is ordered by working with Marketing and Purchasing to acquire and document the correct labels, produce a book that is updated as needed that contains all labels and train production personnel to use book to assure that correct label is applied to jar
Maintain a finished product spec book by working with QA coordinator to photograph finished products and describe finished product
Review HACCP Plan annually and revise as needed by studying current plan and recommending changes and documenting them*
Lead third-party audits and governmental inspections by coordinating the audit team meetings, interfacing with auditor on the day of audit, and coordinate any necessary corrective actions identified by third-party audits or governmental inspections*
Assure that all customer-related quality paperwork is completed in a timely manner and maintain accurate and complete records of all completed forms*
Basic Microsoft Office skills
Ability to read, interpret, and effectively apply government regulations, customer requirements, and industry standards
Good communication skills with all levels of people
Ability to consistently meet tight timelines
Attention to detail
Ability to remain flexible under rapidly changing circumstances, while maintaining a positive attitude
Ability to effectively lead, supervise, and coach staff
Bachelor’s degree in food science or related field
5 years minimum related experience in a similar capacity
Time is primarily spent in a typical office environment but at times requires work in a non-climate-controlled warehouse, kitchen, and manufacturing facility
Requires prolonged sitting and standing
Hours are typically Monday through Friday, 8am to 5pm, with occasional overtime and weekend work.
Occasional travel is required
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Title: Specialist Pharmaceutical Quality Systems
Company: AstraZeneca
Location: Mount Vernon, IN
