Job Description
Essential Job Duties
- Work with quality management to develop, document and implement quality plans, procedures, instructions and test equipment.
- Identify and assure conformance to governmental requirements.
- Conduct in-process and post manufacturing audits of intermediate and finished products
- Ensure manufacturing practices, batch records and other supporting documentation are in accordance with current Good Manufacturing Practices, SOPs and other applicable company policies
- Follows GMP standards, SOP’s, Food Safety Standards as well as workplace safety standards.
- Ensure the traceability of components and products are maintained at every inspection point
- Utilize all documents contained in the Quality System, such as manufacturing procedures, forms, standard operating procedures, and initiate the submission of inspection reports, as appropriate
- Perform additional routine/non-routine audits of manufacturing processes and facilities; and other tasks as assigned
- Partner with Manufacturing and other support groups to provide issue guidance and resolution in alignment with applicable procedures
- The Quality Auditor individual will act as Quality/Operations subject matter expert by providing technical and quality guidance to peers and may facilitate training for incoming staff as well as GMP training for other departments
- This position is expected to identify systemic issues and to collaborate and participate with the process centered organization to implement solutions
- This position will provide real-time issue guidance and resolution, including management of events, will have involvement in continuous improvement activities or other projects to support site goals, execute training and support of internal, partner and agency audits
- Perform detailed root cause investigation and implement corrective actions
Requirements
- High School Diploma or equivalent
- Prior manufacturing experience preferred
- Previous experience in training and/or teaching of others preferred
Competencies
- Ability to motivate and influence people
- Organizing, planning, and problem-solving skills
- Good interpersonal and communication skills
- Ability to work as part of a team
- Effective problem-solving skills and detail oriented
- Be able to work a flexible schedule including daily overtime and weekends Effective communication skills
- Time management skills
- Mechanical aptitude
- Attention to Detail
Physical Demands
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. This is predominantly a highly active in movement role. The job would also require the ability to lift 25 to 50 lbs.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Privacy
Your application for this position is subject to Designs for Health’s Privacy Notice for Job Applicants and Workforce Members. Designs for Health does not sell your personal information, nor does Designs for Health share it for purposes of cross-context behavioral advertising.
Our Commitment to Diversity, Inclusion & Belonging
Designs for Health is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment where all employees can grow and thrive. Our employees form meaningful and often life-long connections while working at Designs for Health. We are all passionate about our mission of designing a well world, together.