About the job
Under general supervision of the Quality Assurance Director, the Quality Assurance Supervisor is responsible for day to day quality operations and quality systems functions. The Quality Assurance Supervisor is a key participant in coaching, training and development of the quality assurance team to ensure high performance and consistent cGMP compliance. The Quality Assurance Supervisor consistently exhibits company values and makes a positive impact on others, the business and the customers we serve.
Primary Duties and Responsibilities:
1. Supervises the Letco Medical QA Operational staff in facilitating day-to-day operations of the Letco Quality Organization.
2. Supervises the quality system processes (such as CAPAs, complaints, investigations, change controls) to ensure on time closures and resolutions that comply with procedures and regulations.
3. Supports and participates in the annual product review (APR) process.
4. Collaborates with Production on release times to establish production schedules.
5. Reviews and approves validated analytical methods for product identification testing.
6. Supports and reviews data for the Letco Medical Container Closure equivalency program.
7. Develops and revises standard operating procedures as needed.
8. Administers facility retain sample program.
9. Performs root cause analysis investigation of customer and supplier complaints, as needed.
10. Performs root cause analysis investigation of internal product quality issues and out of specification in house identification failures.
11. Reviews, assesses, performs impact assessments, and dispositions investigation reports.
12. Generates and executes validation and protocol documentation as needed.
13. Manages the quality assurance hold process.
14. Uses statistics and other data analysis techniques to monitor and improve processes.
15. Utilizes and leads the use of quality tools to solve problems.
16. Prepares periodic quality reports, trend analysis of data, and presentation using key performance metrics, as required.
17. Performs new hire quality training and other quality training sessions, as required.
18. Supports effective staff development and succession planning.
19. Supports all regulatory agency, customer and internal audits.
Set yourself apart
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Experience and Educational Requirements: High School Diploma or GED equivalent required; Associate Degree or Bachelor’s Degree in a science related field or industry equivalent experience preferred; minimum of eight (8) years of progressive responsibilities in quality assurance / control experience preferred; or an equivalent combination of education and experience. Experience in the pharmaceutical industry a plus.
2. Language Ability: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals.
3. Math Ability: Ability to work with mathematical concepts such as probability and statistical inference and apply the concepts to practical situations.
4. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
5. Computer Skills: To perform this job successfully, an individual should be proficient in the Microsoft Office suite of applications including Word, Excel, PowerPoint and Outlook and with Internet Explorer.
What’s on offer?
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success.
Our benefits include, but are not limited to:
• Health, Vision, and Dental Insurance
• Company Paid Life Insurance
• Generous Paid Holidays
• Paid Volunteer Time
• Generous Paid Time Off and Rollover
• Company matching 401K and Retirement Savings Plans
• Employee Assistance Program