The QA Director will be responsible for managing all Quality Assurance activities to include QS, GLP and GMP training and standards, SOPs, Document Control, Audits and support regulatory and quality submissions.

Responsibilities include:

• Direct activities for sourcing of raw materials, product development, manufacturing & characterization
• Oversee Quality System activities including Documentation Control, Internal Audits, Quality Records maintenance, and Management Review
• Interface with US and International compliance and certification authorities as necessary
• Work in a cross-functional team and represent Quality at Product Development team meetings
• Audit and oversee activities of outside contract manufacturers, suppliers and consultants.
• Lead efforts toward continuous Quality improvements

The qualified candidate will have:

• Minimum of 7 years in medical devices, pharmaceuticals or biologics
• 4-year degree required, MS degree preferred

• Broad knowledge of cGMP, ISO requirements for pharmaceuticals and medical devices
• Experience in design control and oversight of design history files
• Experience working in a product development team ensuring both compliance and rapid progress
• Demonstrated ability to manage staff and variable workloads

Industry: Medical Device, Biotechnology

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

Job Code: BHJOB1778_217

The Wellington Group ( http://www.twgrecruiters.com )

Senior SEC Accountant in the Northeast Chicago Area!

The Wellington Group has been engaged to find an experienced Account with solid skills in SEC filings for a well known brand. Join the Team of a growing, dynamic, employee oriented company. The Wellington Group has the job you have been looking for…

Senior Accountant will analyze existing and new accounting and reporting guidance issued by the FASB, SEC, EITF and other regulatory bodies to determine the implications on internal financial operations and external financial reporting and communicating these issues to key management.

Responsibilities include:

• Assists in preparation of internal management reporting in connection with the quarterly filings
• Acts as a consultant on new strategy initiatives to ensure understanding and execution of the proper accounting and reporting
• Stays informed of all material business changes and developments in effort to correctly reflect these events in the financial statements
• Assists in SOX 404 compliance initiativePrepares the Company’s SEC filings on Forms 10-Q and 10-K
• Responsible for preparation of SEC filings, update of the Company’s accounting policies and coordination of the external auditor’s quarterly reviews and annual audits

The qualified candidate will have:

• BS degree in Accounting. CPA preferred
• 4-6 years experience in public accounting and/or SEC reporting
• Previous experience in coordination of external audits for a multi-location accounting organization
• Ability to document and support accounting guidance for accounting department and senior management
• Identify reporting control weaknesses and provide corrective guidance
• Strong analytical/quantitative skills
• Clear and effective oral and written communication skills are critical
• Superior technical skills – MS Excel, ERP system skills (Oracle and/or SAP)

Location:

The North Chicago area of Illinois

Permanent position with an employee centered company offering great benefits, salary and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group has been engaged to find an experienced Senior Internal Auditor for an int’l brand. Join the Team of a growing, dynamic, employee oriented company. The Wellington Group has the job you have been looking for…

Internal Auditors are responsible for performing internal audits of corporate and store functions. The role of the Senior Internal Auditor is to plan and lead financial and operational audits, evaluate and improve internal operations, as well as assist in the documentation and assessment of our internal controls. This role offers invaluable experience with its responsibility and exposure to all aspects of the business.

Responsibilities include:

• Design and execute financial and operating audit programs to address relevant risk and audit assertions.Interpret the significance of audit findings, conclude on findings and make practical recommendations
• Assess new, or changes to existing, processes to identify financial and operating risks before launch and recommending improvements
• Prepare audit reports to document audit scope, procedures, findings and recommendations
• Manage work requirements and budget to meet assigned initiatives
• Support 404 testing and annual management assessment of internal controls over financial reporting

The qualified candidate will have:

• Business/Accounting degree required: CPA and or CIA certification
• Minimum of 5 years work experience
• Good PC skills, including Microsoft Excel and Word
• Strong communication, analytical, and reporting skills
• Strong organizational and leadership skills

Location:

The Triad of North Carolina: Greensboro, Winston-Salem, High Point

Permanent position with an employee centered company offering great benefits, salary and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)