Apple & Associates, Inc.
1 - $1
Reporting directly to the Quality Systems and Compliance manager, the Quality Auditor will have responsibility to audit scheduling, planning, execution and documentation of quality system audits of internal processes for the Greenville location. This position will also be responsible for maintaining a library of standards and for reviewing all applicable regulations, standards and communicating requirements to site leadership. This position will provide cGMP / GXP, technical and auditing development to other QA and operations personnel through participation in the audit processes, management review and cGMP training program ownership.
COMPLIANCE: Ensure the department maintains compliance with cGXP, ISO 9001/ 13485 guidelines and assist with safety and ethical audit compliance. Develop and maintain internal audit schedules. Conduct internal audits as required to meet current regulatory and Global Quality expectations. Assist Supplier Quality Auditor, as needed. (May require some domestic or international travel). Establish, maintain and manage standards library. Ensure periodic review of regulations / standards to include global policies and directives and provide education of those changes to site leadership to ensure compliance. Support administration and execution of external (3rd party) audits. Communicate identified compliance risks to management. Create and maintain written and signed records of all audits and inspections as required. Participate in the preparation and review of files in preparation for audits and regulatory inspections
CONTINUOUS IMPROVEMENT: Identify, evaluate, select and implement continuous improvement and compliance initiatives. Create and edit procedures, policies, specifications and other regulated documentation as needed for process improvement.
SUPERVISING, PLANNING & DIRECTING: Assist in the establishment, management and monitoring of audit related expenses as it relates to the overall departmental budget and spending against stated variances. Establish, communicate and execute against strategic quality and site objectives. Identify, select and develop internal auditors in coordination with departmental management. Promote open communications with the department and internal customers. Schedule and coordinate with site auditors to meet performance attainment of the audit schedule. Provide project support as needed for key plant and global initiatives. Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
KEY RELATIONSHIPS: Internal customers include all departments within the organization. External partners include regional / global quality counterparts, regulatory bodies, independent inspectors, and customers.
BS in a scientific discipline required with CQA or ISO Lead Auditor certification is strongly preferred
Minimum 3-5 years of Quality Auditing or compliance leadership experience in a pharmaceutical/ medical device orGMP regulated
manufacturing environment is required. Strong knowledge of supplier selection, evaluation and auditing programs in the pharmacy, medical device or biologics industries.
Familiarity with EU, Canadian regulations preferred.
Experience in sterile drug products manufacturing preferred.
Experience with conducting cGMP training preferred.
Experience with ISO 9001:2000 / 13485 preferred.
Strong organizational and communication skills required in order to develop programs, work independently with minimal supervision and effectively interact with all levels of the organization, including suppliers.
Demonstrated technical writing and proficiency with Microsoft Office Suite.
Quality Auditor needed at diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
At Apple & Associates, we understand that relationships are what make us stand apart. Whether you are a client or a candidate, you are an extension of the Apple & Associates’ family. Many of our recruiters have been with the company since its earliest days. They take great pride in the relationships they build; always emphasizing high standards, ethics and quality service. Our President, Debi Apple started her recruiting career in Aiken, South Carolina. She quickly became a top producer and leading authority in recruiting for the medical device, pharmaceutical and consumer product industries. Her passion and drive led her to open Apple & Associates in 1993. Under her leadership, Apple & Associates has grown to be one of the leading recruiting firms in these industries. Our company is proud to represent two of the largest medical device and pharmaceutical companies in the U.S., Covidien (formerly known as Tyco Healthcare) and our first and longtime client, Becton Dickinson. Now headquartered in Chapin, South Carolina, Apple & Associates has offices from coast to coast, offering regional recruiting expertise throughout the U.S. and Latin America. Our searches and permanent placements represent all levels, from CEO to staff level positions.