Responsible for managing daily laboratory operations and staff (Chemistry, Microbiology, or Material Science)
Job Description
Responsibilities:
Manage day to day activities.
Ensure priorities and objectives are communicated clearly; projects are completed on time, and compliance with protocols and overall objectives.
Overall responsibility for sample receipt and testing of materials assigned. Ensure equipment in their area is functioning properly calibrated, and all associated documentation is in order.
Lead the creation, review, approval, and execution of lab policies, procedures, and method validations.
Ensure documentation produced in lab is compliant with applicable cGMPs, GOPs, and GLPs.
Review employee-produced documentation including research notebooks, forms, and logbooks.
Prepares for and participates in internal and external audits by regulatory authorities (FDA, EU) and customers.
Responsible for the safety of laboratory personnel/visitors.
Manage laboratory housekeeping and maintenance of non-calibrated equipment/instrumentation.
Fosters and maintains positive relationships with internal and external colleagues ensuring timely and accurate communication.
Management responsibilities include: -
Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments
Day-to-day operations of a group of employees.
May have limited budgetary responsibility and usually contributes to budgetary impact
Interpret and execute policies for departments/projects and develops. Recommend and implement new policies or modifications to existing policies. Provide general guidelines and parameters for staff functioning.
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
Qualifications:
Education Bachelor’s degree in Microbiology, Biology, Engineering or Chemistry. At least 4 years of pharmaceutical, medical device or cosmetic GMP laboratory experience.
Experience assessing and initiating actions independently and acting as project manager.
Experience using time management skills such as prioritizing, organizing, and tracking details.
Experience applying knowledge of ISO 17025 and CFR requirements; experience interacting with FDA/ISO auditors.
Experience applying knowledge and experience working with USP/ASTM/ISO/AAMI/etc test methods.
Experience applying knowledge of FDA requirements and experience with FDA interactions as part of drug and/or device regulatory approval process Additional Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
Technical writing skill and ability.
Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.
Requires the ability to present and communicate with various audiences (e.g. senior management and non-technical audiences).
Position requires up to 10% travel
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. can the underlined be a link to https://www.medline.com/about-us/inclusion-and-diversity/
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.
