Compliance Auditor

Kelly Services
Salisbury, MD
Jan 08, 2022
Jan 21, 2022
Full Time
We are looking for a Compliance Auditor to support one of our clients in MD.Our client is a is US-based generic pharmaceutical business that utilizes its diverse global resources to develop, manufacture and market difficult-to-source products.**Title** : Compliance Auditor**Location** : 207 Kiley Drive, Salisbury, MD 21801**Hours** : M-F 8AM-5PM**Pay** : $70k-80k/year depending on experience**Duration** : Direct Hire**JOB SUMMARY:**The Compliance Auditor is a highly visible operational position of the Corporate Quality Compliance Team. The role of the Compliance Auditor is to ensure that the company is adhering to all GMPs, FDA Regulations and Guidelines, state, federal, and local laws applicable to the business. The incumbent manages Cadista's Internal Audit and Vendor Audit Programs for GMP, GDP and GLP compliance, working closely with the operational functions to define and review processes, procedures, and systems to be audited annually. The incumbent coordinates and develops with GXP operational groups and Quality Systems a holistic Quality auditing strategy.**ESSENTIAL FUNCTIONS:**+ Creates and executes a systematic approach to conduct all audits presenting findings and recommended changes to procedures or practices that are not in compliance with stated regulations and provides technical assistance to implement a plan to address such changes.+ Schedules and conducts internal and external audits that include:1. Reviewing records, reports, and other relevant programs and activities affected by regulations.2. Managing annual calendar for internal audits and vendor audits with updates to the master calendar.3. Planning the scope and scheduling the audit(s) with internal departments, creating audit plan, identifying resources within Cadista to assist with the audit, when applicable.4. Issues audit observations and reports, tracks resolution of audit findings in approved audit tracking system.+ Manages and maintains the Internal Audit and Supplier/Vendor qualification program, including associated SOP's, Approved Vendor List, and Vendor Quality Agreements reporting metrics to Site, Department and Quality management.+ Completes and submits Internal and Supplier Audit reports as per the required deadlines established at the closure meeting requiring minimal edits from the approver.+ Leads internal and vendor GMP, GDP and GLP audit:+ Prepares and reviews audit reports.+ Leads for-cause audits as required to address suspected critical audit findings, fraud, or misconduct related to vendors, or internal processes etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.+ Analyze potential risks within specific areas in order to avoid compliance issues. Performs general risk assessment studies to gauge the possible risk potential of vendors as required escalating critical findings to Corporate and Cadista Quality management.+ Responsible for reviewing progress toward closure of audit findings and reporting the progress to appropriate management. Performs follow-up on all supplied information in order to perform verification checks on proposed corrective actions.+ Supports readiness of the facility for Regulatory Inspection.+ Ensures timely completion of commitments from regulatory agency inspections and partner audits related to audit programs.+ Completes department related Change Controls, CAPAs and Deviations.+ Reviews and evaluates Internal and Vendor audit responses to determine acceptability of the response and any applicable CAPA plans. Performs follow up activity to ensure effective CAPA implementation that resolves and documents issues pertaining to the internal and supplier audits.**EDUCATION & QUALIFICATIONS: Bachelor's in Accounting, Business or Finance**INDUSTRY EXPERIENCE REQUIRED:**+ Minimum five (5) years of related experience, must include extensive knowledge of quality systems within a pharmaceutical or FDA regulated environment.+ Extensive experience in conducting vendor and internal audits.+ Experience in dealing with regulatory authorities desired.**KNOWLEDGE, SKILLS AND ABILITIES:**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required:**KNOWLEDGE:**+ Strong knowledge of all applicable Good Manufacturing Practice regulations and guidelines.+ Ability to scope, assess and control risk.+ Ability to reason logically, analyze and evaluate data and information, and draw appropriate conclusions.+ Understanding of the company operations and practices in the pharmaceutical industry.**COMMUNICATION SKILLS:**+ Demonstrated technical writing skills with the ability to write clearly and concisely conveying the information precisely to the findings and recommendations required.+ Advanced level of written and oral communication skills with the ability to obtain, clarify, or give factual information, interpret instructions, and record data.+ Ability to build and maintain effective business partner relationships with varied levels of staff.+ Active listening skills demonstrating the ability to give full attention to what others are saying, understanding the points being made, and asking the appropriate questions during the audit process.**COMPUTER SKILLS** :+ Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and TrackWise.Don't Wait! Apply Today!**Please APPLY NOW if you are interested and then text John at 412.909-4347 for more information. Why Kelly** **(R)** **?**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** **(R)**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.