Job Summary
Direct and coordinate the activities of employees engaged in the scientific testing of raw materials, in-process materials and finished goods. Develop laboratory staff understanding and utilization of FDA requirements, as well as ISO and ICH guidance. Prepare employees to engage with FDA, ISO registrar, vendors, suppliers, and customers as it relates to the Laboratory. Evaluate laboratory processes and cross-functional interactions for continuous improvement opportunities.Job Description
Responsibilities:
Direct and coordinate the activities of lab technicians including chemical and microbiological testing of raw materials, in process materials, finished goods, stability and project support as assigned.
Confer with other supervisors to coordinate operations and activities within or between departments. Serve as a technical liaison between quality control and other departments, vendors, or contractors.
Participate in out-of-specification and failure investigations and recommend corrective actions.
Assist in troubleshooting any quality concerns throughout facility.
Write or review technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
Develop or update procedures, policies, or standards. Write and review SOP's, batch production records, quality records, and general documentation. Research, compile, and prepare reports, manuals, correspondence, or other information required by management or governmental agencies.
Evaluate laboratory practices and process for improvement opportunities while ensuring drug/device/cosmetic requirements are met.
Monitor training and qualification of laboratory technicians to ensure compliance to SOPs and regulatory requirements.
Evaluate laboratory processes and cross-functional interactions for continuous improvement opportunities.
Assist Quality Department interfacing with FDA, ISO registrar, vendors, suppliers, and customers as it relates to Laboratory and Good Manufacturing Practices including responding with corrective/preventive actions when non-conformances are found.
Management responsibilities include:- Responsible for the daily activities and outcomes of a group of employees.
Hiring staff, recommending pay increases, conducting performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
Support and execute laboratory budget.
Qualifications:
Bachelor's Degree in a technical discipline such as Chemistry, Microbiology, Engineering.
At least 3 years of lab experience in the Medical Drug/Device Industry. Experience with mentoring junior staff.
Experience applying knowledge of laboratory quality systems & regulatory requirements (such as ISO 13485, 21 CRF Part 210/211 and QSR part 820). Technical writing experience in an FDA regulated industry.
Position requires travel up to 10% of the time for business purposes.
Preferred Qualifications:
At least 2 years of experience in laboratory supervisory or other technical supervisory role.
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.
