Supervisor/Manager-Commercial at Sandpoint

Job Description

Job Classification: Direct Hire We are currently looking for a candidate who is able to step into a senior management position as a Director of Quality and Regulatory Affairs. This individual will be responsible for establishing, implementing and assuring quality and regulatory control in the manufacturing facility. This individual will be responsible for providing expertise and guidance in interpreting governmental regulations and internal policies to assure compliance. This Individual will partner with all departments to establish and drive company quality systems and strategies. Duties:Responsible for all regulatory compliance programs for the companyDevelop, implement and maintain Quality Management Systems to ensure compliance with FDA and other regulatory requirements.Conduct management reviews with QMS.Direct the internal audit process, including the oversight of GMP audits of the production facility on a regular scheduled basis.Primary contact for all external audits, including FDA, ISO and customer auditsReview Customer and regulatory requirements to ensure compliance and to stay abreast of new updated regulationsPrimary FDA contact, including completing the annual FDA registration updates and keeping Drug and Device listings currentConsult in reviews of non-conformances to ensure trends of systematic issues are identified and addressed.Audit records of finished products for compliance with manufacturing procedures and GMPs to ensure quality and regulatory complianceAnalyze audit data and prepare records for management review and continuous improvement initiativesPerform external quality audits on suppliers to ensure compliance with product specificationsOversee the maintenance of quality system records for facility and all Change of Control activities to ensure complianceReview all released documents to ensure compliance with Standard Operating Procedures Support company growth initiatives by working with other departments to ensure new products, processes and plans are delivered within time frames and guidelinesEstablish, prepare, implement, revise and maintain policies and procedures related to Quality provide employee leadership through effective communications, coaching, training and developmentOversee Corrective and preventative Action programOversee quality control laboratoriesOversee all validation activities Provide regulatory guidance for new product introduction including labeling review, development of specifications and risk managementPreferred Qualifications:Bachelors Degree in Chemistry, Engineering or a related fieldMinimum of 10 years experience providing GMP regulatory compliance in Manufacturing of Quality AssuranceMinimum of 5 years experience in an FDA manufacturing facilityDetailed knowledge of GMP, ISO and FDA requirementsProven experience implementing quality systems in a GMP environmentAuditing certification preferredExcellent analytical and problem solving skillsAbility to manage multiple projects and prioritize to meet established timelines

Join Aerotek, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, were constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know its more than just your day-to-day responsibilities that can make or break a job. Its the support you get. Thats the reason Aerotek offers a variety of benefits including medical, dental, optical, 401k, and many more. Dont put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.

Job Requirements

• Supervisor - Uncategorized, QUALITY ASSURANCE/QUALITY CONTROL, Chemistry Degree, MECHANICAL ENGINEER DEGREE, FDA, GMP REGULATORY

Country: USA, State: Idaho, City: Sandpoint, Company: Aerotek.