|
Job Title:
|
Supplier Quality Specialist
|
|
Company:
|
KV Pharmaceutical
|
|
FLSA Status:
|
EXEMPT
|
|
Salary/Hourly:
|
Salary
|
|
State:
|
Missouri
|
|
City:
|
St. Louis
|
|
Employment Type:
|
Regular
|
|
Job Description:
|
Supplier Quality Specialist
Local Candidates Preferred. No Relocation provided. Internal Candidates will be given preference for the first 10 days of the initial positing.
POSITION OVERVIEW
KV Pharmaceutical has a opening for an experienced Supplier Quality Specialist to join our Quality Assurance department. As the Supplier Quality Specialist, your main responsibilities will be to assure that our suppliers of raw materials/components and third party manufacturers/packagers are in compliance with cGMPs and ICH Q7, as appropriate, by conducting audits and monitoring performance. You will also provide daily quality oversight of external manufacturers by evaluating change control activities, monitoring manufacturing/ packaging incidents, and conducting supplier audits.
Your experience with Supplier Quality will be needed as you will be responsible for initiating action to address any significant issues and alert management. From the results of the audits, you should be able to identify opportunities for improvement, assess performance of the manufacturing sites or suppliers, and identify possible causes for noncompliance. Finally, you will serve on various project teams focused on alternate vendor projects and external manufacturing. In some teams, you may be asked to use your previous experiences to provide team leadership and support. In this position, you will adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
KV Pharmaceutical is seeking individuals who possess excellent verbal and written communication skills, offers an organized approach to providing timely accurate reports, can multi-task, prioritize, and is proficient in Microsoft Office.
MINIMUM QUALIFICATIONS
Knowledge/Skills/Abilities
• Must possess in-depth understanding and application of regulations pertaining to the manufacturing of pharmaceuticals. Must exhibit strong interpersonal communication skills.
• Familiarity with a manufacturing, packaging and testing environment involving solid dosage forms.
• Ability to travel domestically and internationally, often with short notice.
• Highly-developed auditing skills.
Education/Experience
• Bachelors degree in Chemistry, Engineering or Science or equivalent combination of 4-year degree and work experience
• 5 years experience in the pharmaceutical or medical device industry in the area(s) of manufacturing, quality control/assurance, product development or technical services.
COMPANY OVERVIEW
KV Pharmaceutical (NYSE: KVa/KVb), is a fully integrated specialty pharmaceutical company that develops, manufactures, markets and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology-distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its emerging branded drug subsidiary.
KV is based in St. Louis, Missouri, which was recently named as a 2008 All-America City by the American City Business Journals, one of Forbes’ “200 Best Metropolitan Areas” in America in 2006. St. Louis was also named the second most affordable large metropolitan area in the country by the National Association of Home Builders in 2005.
St. Louis offers a world-class medical community with over 50 general practice, teaching and research hospitals including Washington University and St. Louis University. St. Louis is also rich in education with more than a dozen nationally-recognized four-year universities.
KV Pharmaceutical will provide a competitive compensation package in addition to a comprehensive benefits package including a 401(k) and profit-sharing, health, vision, and dental.
KV Pharmaceutical is an Equal Opportunity Employer. M/F/D/V
|
|
Interest Category:
|
Quality Assurance
|
|
