Quality Control Lab Manager
We are looking for an experienced and proactive Quality Control Lab Manager who will have the primary responsibility for ensuring that finished drug and non-drug products are conforming to pre-determined specifications performed at McKenna Labs 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.
- 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.
Leadership and Team Management:
- Manage resources and timelines for staff performance.
- Develop and perform training programs for staff.
- Lead and support staff's inspection activities and provide technical direction as needed.
Process Optimization:
- Work cross-functionally to streamline workflows and eliminate bottlenecks.
Capital Projects and Budget Management:
- Working closely with internal teams, develop, manage, and support capital improvement projects to enhance plant capabilities and capacity.
Continuous Improvement Initiatives:
- Drive continuous improvement initiatives to optimize manufacturing performance, reduce waste, and increase overall efficiency.
Requirements
To fulfill the requirements of 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 accommodations 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 plusses).
- 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.
The salary range for this role is $90,000 - $125,000 annually. Compensation is commensurate with level of knowledge, education, skills, and experience applicable to the position.
We understand that each team member's situation is unique, and so it is our intent to offer an overall benefits package that can be shaped and molded by each individual to fit their family's needs. Our current benefits package, which is available to all full-time team members, includes medical, dental, vision insurance, 401k retirement plan, flexible spending accounts, life and disability coverage, and other voluntary benefits.
We want everyone to feel welcome, respected and we are committed to providing the best space, experience and workplace for our teams - no matter what race, color, religion, sex, sexual orientation, gender identify, national origin, veteran or disability status and all the other fascinating characteristics that make us different.
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