Job SummaryDirect 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.
2nd shift: 3PM-11PM
Job DescriptionMAJOR 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.
MINIMUM JOB REQUIREMENTS:Education:- Bachelor's Degree in a technical discipline such as Chemistry, Microbiology, Engineering.
Certification / Licensure:Work Experience:- 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.
Knowledge / Skills / Abilities:- Position requires travel up to 10% of the time for business purposes.
PREFERRED JOB REQUIREMENTS:Education:Certification / Licensure:Work Experience:- At least 2 years of experience in laboratory supervisory or other technical supervisory role.
Knowledge / Skills / Abilities:The anticipated salary range for this position:
$79,000.00 - $119,000.00 Annual
The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
