Sr. Quality Specialist

Job summary:

The Sr. Quality Specialist position is responsible for reviewing quality systems and compliance in all areas of operations to include change management oversight, compliance and quality data review, audits and inspections, deviation management, non-conforming product evaluation, qualifications and validations, SOP review and approval, document control, Quality Management System (QMS) administration, and regulatory affairs and serves as a resource to operations on quality issues.  The Quality Specialist participates in performance improvement initiatives through data and process analysis.

Primary responsibilities:

• Perform site quality assessments as required in compliance with internal policies & procedures and regulatory requirements
• Conduct scheduled or random quality inspections
• Assist assigned site during customer, supplier, or regulatory body visits
• Analyze data utilizing analytical methods and statistical techniques that support and/or measure performance, investigations, sample planning, improvements, corrective actions, preventive actions, implementations, and effectiveness in evaluating internal processes and external performance
• Collaborate with cross-functional teams to identify areas for process improvement, risk mitigation, and quality enhancement
• Execute validations and qualifications, to include completing documentation requirements
• Assist with document control in the Quality Management System
• Conduct thorough root cause analyses and implement corrective and preventive actions to address quality issues
• Assemble supporting documentation to detail the specifics of potentially non-conforming product events.
• Stay current and support compliance of both internal and external regulatory requirements (e.g., FDA/OSHA/NABP/State)
• Participate in other Quality processes like Change Control, Quality Risk Assessment & mitigation
• Monitor that equipment preventative maintenance is scheduled and performed on time
• Monitor monthly temperature monitoring reports to identify trends
• Verify workplace safety processes are followed
• Possess high motivation, enthusiasm, and dedication to our team and customers.
• Deliver quality customer service to all team members, customers, and stakeholders
• Perform all assigned duties in keeping with the Enterprise’s core values, policies, and all applicable regulations
• Bring any compliance issues to the attention of management
• Perform all other duties as assigned by management

Required competencies, knowledge, skills, and abilities:

• Proficient computer skills
• Proficient in Microsoft Office products
• Ability to organize, prioritize, and execute a variable workload and multiple priorities
• Ability to maintain confidentiality, high integrity, respect, flexibility, service excellence, and teamwork
• Ability to provide high levels of customer service and work effectively with all levels of staff and management
• Ability to work independently and in a team environment
• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities
• Must be able to pass a drug test and background check aligned with state and federal laws and regulations

Required certifications, licenses, education, and experience:

• Bachelor’s degree or equivalent work experience.
• Four years on-the-job experience in healthcare, pharmaceutical industry, or other regulated industry

Preferred education, competencies, knowledge, skills, and abilities:

• STEM background
• Good writing, grammatical and editing skills
• Good communication and organizational skills
• Solid knowledge of lean sigma methodologies required
• Critical thinking skills
• Ability to investigate issues to root cause and develop safeguards from event(s) occurring again
• Commitment to continuous improvement with demonstrated success in leading and influencing team members
• Proactively identifying potential issues to prevent their occurrence
• Strong attention to detail and accuracy
• Experience with MasterControl or other computerized quality management systems is a plus

Physical demands and work environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods sitting at a desk and working on a computer and/or phone
• Visual acuity to accurately read small print in contracts, RFPs and other documents
• Ability to stand, walk, bend, squat, stretch, kneel, reach, grasp, and pinch
• Ability to stand or walk in the warehouse environment for prolonged periods of time
• Physical ability to occasionally lift, carry, push, and pull up to 40 pounds