Compliance Specialist

Kelly is pleased to offer a Direct Hire opportunity for a Compliance Specialist position with a premier employer in Salisbury, MD.

We are excited to partner with a large US-based pharmaceutical business!

Salary: Competitive!
Work Schedule: Monday-Friday, 8am-5pm
Location: Salisbury, MD

POSITION SUMMARY

The QA Compliance Specialist promotes an effective pharmaceutical quality system that aligns with the organization’s quality concepts including GMP regulations and quality risk management elements that are implemented through the different stages of the product life cycle. The incumbent maintains all elements of the Quality Systems ensuring compliance with current GMP regulations, Corporate and HR Policies, FDA, and any other regulatory requirements. This incumbent proactively prevents compliance gaps and leads process improvement efforts.

ESSENTIAL FUNCTIONS

• Ensure compliance with current Good Manufacturing Practices (cGMP) regulations as per current industry trends and agency expectations.
• Facilitate innovations and continual quality improvements, process improvements, non-conformance reduction, and quality system enhancements.
• Assess and enhance quality risk management systems that will provide proactive approaches to identifying, evaluating, and controlling risks to current quality systems.
• Monitor and review process performance and product quality monitoring systems to maintain a continuous state of compliance.
• Stay abreast of regulatory changes and industry best practices regarding compliance and strive to implement continuous enhancements to the company’s procedures. · Initiate SOP updates and improvements, as appropriate.
• Maintenance and coordination of the Stability Program that monitors products over expiry, as appropriate. . · Initiate/perform/review documentation including deviations, change controls, CAPAs, and drug product complaints, as appropriate.
• Perform drug product annual product reviews (APRs).
• Perform weekly/monthly/quarterly trend reports/presentations for quality metrics and interpret trends for proactive corrective actions.
• Perform QA oversight of cGMP areas and assist in internal audits, as appropriate.
• Assist during regulatory agencies inspections, such as FDA and/or during internal company audits.

EXPERIENCE AND QUALIFICATIONS:

EDUCATION

• Bachelor’s degree in a scientific or related industry discipline.
• Minimum of two (2) to five (5) years of quality experience preferably in the pharmaceutical industry – FDA REG./ISO

#CB

Why Kelly®?

You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.