Job Summary
Job Description
JOB SUMMARY:
Assist the Quality Assurance Manager with personnel, quality and regulatory oversight support.
Assist with managing the activities of the quality control group to ensure quality and regulatory compliance for assigned division.
CORE JOB RESPONSIBILITIES:
- Assist the QA Manager with personnel, quality and regulatory oversight support including the daily operation of the unit.
- Perform quality and/or regulatory reviews of labeling and other documentation for compliance with stated requirements including applicable OTC drug monographs, procedures and quality records.
- Assist the division in product evaluation from a quality assurance and regulation compliance standpoint. Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
- Review all purchased products or components and provide input to the decision of whether to accept the product and future purchases from the vendor.
- Manage complaints and develop new approaches to solve problems identified during quality assurance activities.
- Assist in preparing reports to communicate involvement and results of quality assurance activities.
- Prepare and present technical and program information to team members and management.
Education
- Bachelor's degree in Biology, Chemistry, or related science and Engineering.
Relevant Work Experience
- At least 3 years experience in pharmaceutical or medical device good manufacturing practices. Additional - Intermediate computer skill level.
- Experience applying knowledge in project management.
PREFERRED QUALIFICATIONS:
- Relevant Work Experience
- Experience in drug product manufacturing and drug regulations.
- Experience in the indirect management of team members, including assisting in the development, training, and assignment of work/projects.
Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.
Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
