SUMMARY OF POSITION:
This position is responsible for managing Quality Management systems (QMS), Document Controls and Training.
Responsible for Quality related business systems (QMS) such as NCR, OOS, Complaint, Deviation/CAPA, by contributing and reviewing for approval and assisting with the implementation and supporting on-going continuous improvements.
This Managerial position must have a strong knowledge and application of the CFR's and cGMP's (familiar with multiple regulatory jurisdictions both domestically and international)
List of Responsibilities
* To ensure that quality system requirements are effectively established and maintained.
* To ensure that the production records and testing results are complete, accurate and documented according to established written procedures.
* To ensure deviations from established procedures are documented per procedures.
* To ensure that all changes that potentially impact product quality are documented per procedure.
* Provide support to QA- Operation in quality decision making on the manufacturing floor.
* SOPs/Document Management: Approve all instruction sets, specifications, sampling instructions, test methods etc. and other Quality control procedures directly related to operations and other cGMP activities.
* Responsible for Document organization and retention.
* Deviation/CAPA Management approval: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
* Complaint Management approval: Ensure all customer complaints are appropriately documented and investigated to determine and fix root cause.
* Responsible for Annual Product Reviews.
* Responsible for Training Program.
* Provides support to the Auditing Program.
* Advises site management regarding Quality Assurance issues.
* Supervises staff, providing performance appraisals, hiring, and handling all staff relations issues.
* Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes.
-Bachelor's degree in chemistry, biology, or related scientific discipline and a minimum of seven (7) years managerial experience in the same or closely related GMP environment.
-Experience leading both internal audits, identify findings, drive resolution and provide closure report.
-Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
* Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
* Excellent oral and written communication skills with strong technical writing experience required.
* Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
* Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
* Strong computer operation skills including word processing, presentation, database and spreadsheet application skills.
* Proficient skills in solving complex problems and ability to bring issues to resolution.
* Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.