16 days old

Compliance Specialist - Pharmaceuticals (direct hire)

Kelly Services
Largo, FL 33778
**Compliance Specialist (direct hire)**

**Overview:** Kelly Services is seeking a motivated, enthusiastic individual to join our clients team as a Compliance Specialist. This is a direct hire position based in Largo, FL for a privately-owned pharmaceutical company. This position offers a competitive total compensation package, including health benefits (medical, dental, and vision), 401k with company match, life insurance, and paid vacation and personal time.

The Compliance Specialist is responsible for overseeing the Supplier Quality Management Program for GMP suppliers and other contract service providers, as needed. The individual in this role will be responsible for initial supplier assessments, supplier qualification, quality agreements, and ongoing supplier oversight working closely with functional area colleagues. The incumbent will assure individual compliance with the FDA regulations, cGMPs and all other

applicable international regulatory compliance requirements, applicable department programs, including training, documentation, standard operating procedures, and other policies and procedures.

**Job Responsibilities:**

- Manage the sites Internal Audit Program and that all system audits are conducted at the specified frequency.

- Create, review approves and track corrective actions related to internal audits.

- Develop the annual internal audit schedule and keep current throughout the year.

- Facilitate the scheduling of audits and development of agendas for internal audits. Lead/Participate in audits.

- Supports the supplier qualification and re-qualification management program. This will also include out-sourced Labs and GMP Contract Services Providers.

- Support the Inspection Management/Inspection Readiness programs.

- Coordinate and manage the Quality Council Meetings. Gather metrics, prepare slide presentation and schedule meetings. Preparation of minutes and ensure follow-up actions are completed.

- Collect, review, and analyze data to process all the Annual Product Review (APR) reports within the established due date.

- Support Field Alert Report and Recall investigations and gather data to file any potential Recall and Field Alert Reports, or reporting actions.

- Coordinate Escalated Quality Events meeting including the preparation of minutes and follow-up on pending actions.

- Maintains approvals/licenses for existing marketed products of state and out-of-state licenses for the company.

- Coordinate and prepare licensing applications, filing of all license reports and renewals in all currently licensed states as well as new licensing as state laws change.

- Interact with the FDA, DEA and other Regulatory Agencies in support of inspections and information requests.

- Responsible for trending of compliance metrics.

**Qualification and Requirements:**

- B.S. degree in physical or life sciences required

- Five (5) years of related work experience as a leader in Quality Assurance, and three (3) to five (5) years with direct exposure to, or knowledge of, pharmaceutical quality assurance/control and regulatory affairs is required.

- Ability to work independently and make quality/compliance-based decisions

- Excellent project and data management skills and a keen attention to detail

- Excellent communication skills for both written and verbal presentations

- Evidence of strong strategic thinking, planning and organizational skills

- Experience implementing and maintaining quality systems as well as audit and regulatory experience preferred

- Auditor certification, GMP manufacturing experience, experience with commercial products, and/or experience managing pre-approval and routine GMP inspections are desirable.

Please note that resumes from third parties will not be accepted. All candidates must be presently authorized to work for any employer in the US.

Apply today for immediate consideration or send your resume directly to


**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-05-28 Expires: 2021-06-28

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Compliance Specialist - Pharmaceuticals (direct hire)

Kelly Services
Largo, FL 33778

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast