Quality Compliance Specialist (Decatur, AL)

Quality Compliance Specialist (Decatur, AL)

23 Apr 2024
Alabama, Huntsville / decatur 00000 Huntsville / decatur USA

Quality Compliance Specialist (Decatur, AL)

Vacancy expired!

CAREER OPPORTUNITIES AT LETCO MEDICAL

Are you looking for a Quality Assurance career opportunity in the pharmaceutical industry in the Decatur, Alabama area? Do you want to capitalize on your talents and realize your goals?

Letco Med is currently accepting applications for a Quality Compliance Specialist at our Decatur, Alabama Distribution Center. Successful candidates will participate in an intensive Quality training program with a curriculum including advanced knowledge of the compounding pharmaceutical industry using Letco Meds proven methodologies.

ABOUT OUR COMPANY:

Letco Medical, L.L.C. (Letco Med or Letco), a 100% employee-owned company headquartered in Wayne, PA, is the supply partner of choice for profit-conscious compounding pharmacies everywhere. Letco Med has invested heavily in building a company that can serve the needs of compounding pharmacists today, tomorrow and into the future, with a full line of products and complementary programs and services. With a dedicated focus on the U.S. compounding market, Letco Med provides a broad and comprehensive portfolio of safe and consistent top-quality chemicals, compounding supplies and equipment at highly competitive prices. Letco Meds product line includes chemicals covering a broad range of therapeutic categories, as well as supplies, equipment, capsules, pre-made topical bases, and oral delivery vehicles. Letco Med also carries a deep assortment of dosage forms and delivery systems.

Since its inception in 1993, Letco Med has earned and built a reputation as one of the most innovative companies in the compounding industry. Letco Med is focused on unwavering quality, exemplified by the companys industry-leading quality assurance programs, stringent quality control procedures and an unmatched record with the FDA.

At Letco Med, our main focus is our customer, and we pride ourselves on providing service excellence in every aspect of our business, including how we treat our associates.

We offer a work environment that promotes a culture of teamwork, professionalism and executing with excellence, along with a progressive benefits package for full-time associates including company-subsidized medical and dental insurance; company-paid basic life insurance and disability benefits; 401(k) plan with company match, paid holidays, earned time off and more.

Your search is over. Join the Letco Med team and make a career choice that is both challenging and rewarding!

ABOUT THE JOB: QUALITY COMPLIANCE SPECIALIST

The Quality Compliance Specialist ensures customer issues are resolved in compliance with Letcos document and investigative quality systems. The Quality Compliance Specialist collaborates with the Production team to ensure effective root-cause analysis investigations are performed identifying appropriate corrective/preventative measures. In addition, the Quality Compliance Specialist coordinates collection of quality metric trend data, serves as document control room administrator, facilitates the document change control process, serves as a module manager of the electronic quality management system, and supports regulatory and third-party audits. The Quality Compliance Specialist always maintains positive and cooperative communications with all levels of associates, customers, vendors, and other third parties

PRIMARY DUTIES AND RESPONSIBILITIES:

1 Facilitates compliance with all quality system processes to ensure on-time resolution and closure.

2 Administrator of the document control system; provides document change control approvals.

3 Serves as a module manager within Verse Solutions, an electronic quality management system.

4 Collects and reports quality metrics using key performance indicators (KPIs).

5 Develops and revises standard operating procedures (SOPs).

6 Delegates assignment of customer and supplier complaint investigations.

7 Performs or assists in investigations of internal quality issues or investigation approval.

8 Documents quality assessments and finding reviews related to complaint investigations; drafts customer response letters for approval.

9 Performs/assists with customer/supplier complaint investigations; provides investigation approvals.

10 Performs CAPA investigations, implementations, and/or effectiveness checks.

11 Distributes associate training status reports and other open quality system reports.

12 Supports regulatory and third-party facility audits.

13 Other duties as required.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

High School Diploma or GED equivalent required; associate or bachelors degree in a science related field or industry-equivalent experience preferred; minimum of five (5) years of progressive responsibilities in quality assurance/control experience required; or an equivalent combination of education and experience. Experience in the pharmaceutical industry a plus.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

 Strong interpersonal skills; ability to make personal connections with teammates and customers.

 Ability to write reports, business correspondence, and procedure manuals that are grammatically correct.

 Ability to define problems, collect data, establish facts, and draw valid conclusions.

 Ability to interpret technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 Articulate and courteous manner.

 Good decision-making skills.

 Ability to work in a fast-paced environment and manage multiple tasks simultaneously.

 Ability to work effectively in a team environment.

 Strong organizational skills; attention to detail.

 Proficient in Microsoft Word, Excel and Outlook and with Internet Explorer / Google Chrome.

 Experience in the healthcare, compounding pharmacy, and/or pharmaceutical industries preferred.

To be considered for the Quality Compliance Specialist position, please apply through our Careers page at www.LetcoMed.com.

We look forward to welcoming you to the Letco Med team!

Letco Med is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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