QC Lab Manager — Lead Micro & Analytical Teams

Socket.dev; Fullerton (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Socket.dev in Fullerton, CA, seeks a Quality Control Lab Manager to ensure finished products meet specifications and lead Micro and Analytical teams. You will drive CAPA investigations, data analytics, and cgMP compliance while collaborating with cross-functional partners onsite.

You’ll supervise QC staff, manage raw material, in-process, finished goods, and stability testing; review specifications; establish SOPs; and pursue continuous improvement to support product launches and regulatory

Qualifications

• 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.

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

Skills

Leadership

Problem solving

Cross-functional teamwork

Coaching and development

Fluent English

Education

Bachelor’s degree in Chemistry or Microbiology

Tools

ERP Systems

MS Office

Job description

Socket.dev in Fullerton, CA, seeks a Quality Control Lab Manager to ensure finished products meet specifications and lead Micro and Analytical teams. You will drive CAPA investigations, data analytics, and cgMP compliance while collaborating with cross-functional partners onsite.

You’ll supervise QC staff, manage raw material, in-process, finished goods, and stability testing; review specifications; establish SOPs; and pursue continuous improvement to support product launches and regulatory