Quality Control Lab Manager

Summary

The Quality Control Lab Manager has the primary responsibility for ensuring that finished drug and non-drug products are conforming to pre-determined specifications to either meet or exceed customer’s expectations. This includes overseeing the daily operation of the Quality Control teams (Micro and Analytical) with the responsibility of leading failure investigations, CAPA follow-up, as well as supporting both the company and department strategies by analyzing key metrics and trends along with verifying strategic effectiveness.

Key Duties and Responsibilities 

• Provide strong leadership to Quality team members, fostering a culture of continuous improvement that is collaborative, empowering, and motivating.
• Manage Quality Control activities and staff.
• Support and enforce Microbiology and Analytical requirements.
• Manage and be responsible for all aspects of raw material testing, in-process bulk testing, finished goods testing, stability/compatibility testing, and documentation practices as required.
• Review and maintain product specifications and masters.
• Establish and maintain SOP criteria as it pertains or relates to Quality Control.
• Collaborate with customers to drive positive quality-to-quality partnerships.
• Monitor cGMP compliance in the work environment to diagnose and correct improper quality practices per cGMP.
• Responsible for quality metrics that support strategic decisions using data analytics and key performance indicators.
• Understand, exercise, and enforce safety requirements and procedures.
• Perform non-routine experimentation/problem solving investigations.
• Lead failure investigations (non-conformances, customer complaints, OOS) and facilitate involvement from other departments as appropriate.
• Build department capability and capacity to meet both the current and future needs of the business through talent acquisition, employee training/development and performance management.
• Manage purchase of new equipment and repairs/maintenance as well as other related supplies for staff.
• Support continuous improvement of the Quality Systems.
• Ensure that batch records are reviewed and are completed appropriately.
• Support new product development and tech transfers as required from a Quality Control perspective.
• Perform and ensure employees perform duties in compliance with company policies, safety rules, Standard Operating Procedures (SOP’s), Good Manufacturing Practices (GMP’s), and federal & state regulations.
• Set clear goals and performance targets, monitor progress, and provide constructive feedback to team members.
• Contribute to an environment in which all team members are respected regardless of their individual differences.
• Work directly with cross-functional leaders to finalize quality control related needs

Production Process Optimization:

• Collaborate with internal and external groups to analyze production processes, identify opportunities for improvement in efficiency and productivity, and provide insights for the development of identification and standardization of best practices to drive both compliance excellence and efficiency.
• Work closely with production and operations teams to streamline workflows and eliminate bottlenecks.

Continuous Improvement Initiatives:

• Drive continuous improvement initiatives to optimize production performance, reduce waste, and increase overall efficiency.
• Apply manufacturing management principles to troubleshoot complex technical issues and provide innovative solutions.
• Conduct or review studies for the implementation of new equipment, technologies, and processes.

Requirements

To fulfill the requirements of the job successfully, an individual must be able to perform each essential duty at a high level. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 5+ years of experience in a regulated manufacturing environment or 2+ years of supervisory experience in a regulated manufacturing environment.
• Experienced leader in managing and developing microbiology and analytical laboratories.
• Bachelor’s degree in Chemistry, Microbiology or related field.
• Knowledge of computer applications (i.e. Microsoft Office) and ERP Systems. RedZone familiarity is a plus.
• Comprehensive knowledge of Good Manufacturing Practices (GMPs) and Regulatory Guidance Documents as they relate to quality release of personal care and OTC products is required (FDA 21 CFR 210/211 or ISO22716 are pluses).
• Strong ability to deliver high-quality results in a fast-paced environment while coaching, developing, and motivating others.
• Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues through improved process, resource management, or new technology.
• Excellent cross-functional team skills to accomplish cross-functional initiatives / goals with leaders from manufacturing, quality assurance, supply chain, product compliance, and warehouse.
• Fluency in English. Bilingual in technical Spanish is a strong differentiator.
• Must be able to work in person onsite.

Physical Requirements

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel. The employee is regularly required to stand, walk, sit, reach with hands and arms, or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and fumes, airborne particles, and pathogenic organisms. The noise level in the work environment is usually moderate.

Supervisory Responsibility

This position has supervisory responsibilities