Location: Portage,IN, USA
Job Title: QC Lab ManagerJob Description
We are seeking an experienced QC Lab Manager to lead our Quality Control Laboratory operations within a dynamic pharmaceutical manufacturing environment. This role involves directing laboratory personnel, managing workflows, and ensuring compliance with regulatory standards. The successful candidate will foster a culture of teamwork, efficiency, and continuous improvement while maintaining high standards of product quality.
Responsibilities
+ Direct Quality Control Laboratory Operations.
+ Design, develop, implement, and maintain the Training Program for laboratory personnel.
+ Plan, assign, and direct all work within the laboratory, including Finished Product Release, In Process Release, Raw Material Release, and Stability Testing Release.
+ Coordinate all work utilizing third-party services and maintain efficient and compliant programs for sample receipt and tracking, sample testing, data generation and analysis, instrumentation control and calibration, reference standard control, chemical inventory control, data reporting, documentation, and other general laboratory systems.
+ Ensure and enable completion of activities in compliance with applicable procedures, specifications, and compendia requirements.
+ Design and modify workflows to guarantee the highest quality of data and highest efficiency of resources.
+ Manage direct reports through training, development, coaching, and evaluation to ensure high quality, technical integrity, and productivity of work performed.
+ Set goals for direct reports and conduct performance reviews; manage the hiring process within the QC group and participate in candidate selection as necessary.
+ Provide technical expertise to internal teams and external partners, document and implement programs, systems, and procedures for monitoring and ensuring product quality.
+ Evaluate new procedures, software, and equipment for use within the laboratory. Interact with vendors to ensure quality of any items purchased.
+ Establish and maintain key performance metrics for the laboratory.
+ Review and evaluate the effectiveness of company policies, procedures, specifications, and test methodologies; identify and correct problems and assure the adequacy of resources.
+ Canvas global industry improvements, changes, and forums, applying relevant information internally.
+ Continually review programs and systems to develop and drive improvements in efficiency, effectiveness, and quality.
+ Author, edit, review, and approve technical studies and reports, protocols, specifications, and SOPs.
+ Understand budgeting, staffing, payroll, and purchasing processes. Prepare budgetary information and operate the laboratory within assigned budgets.
+ Lead independent and team-based investigations. Determine root causes for Out of Specification and Atypical test results, propose and monitor corrective actions.
+ Support customer complaint investigations as required.
+ Ensure a high level of internal and external customer support.
+ Work closely with others in a team environment and act as an integral team member on multidisciplinary teams supporting Manufacturing and Product Development activities.
+ Interpret and communicate quality control philosophy to key internal and external personnel.
+ Maintain an active role in driving continuous improvement initiatives.
+ Formulate, document, and maintain quality control standards and ongoing quality control objectives.
+ Coordinate objectives with production and product development activities in cooperation with other managers to maximize product reliability and minimize costs.
+ Demonstrate proficiency in computer use (Word, Excel, PowerPoint, etc.) including the ability to learn and master new computer applications.
+ Ensure regulatory compliance in maintaining instrumentation records, test result documentation, usage logbooks, maintenance logbooks, and all other product or project-specific documentation with attention to accurate record-keeping.
+ Display excellent problem-solving ability.
+ Interact with internal and external auditors and assist in performing internal and external audits.
+ Manage non-routine projects as required.
Essential Skills
+ BS/BA degree in a scientific discipline; advanced degree preferred.
+ 10+ years of laboratory experience with at least 5 years in a pharmaceutical laboratory or regulated environment and 3-5 years of management experience.
+ Proven expertise in analytical skills, instrument techniques, and test method development.
+ Experience in test method validation.
+ Ability to handle multiple assignments and projects with competing priorities while independently managing time.
+ Highly motivated, self-directed, detail-oriented, with strong organizational skills.
+ Operates with a sense of urgency in a fast-paced environment.
+ Detail-oriented, quality-minded with excellent oral and written communication skills.
+ Proficiency in computer use (Word, Excel, PowerPoint, etc.) with the ability to learn and master new computer applications.
+ Excellent technical writing skills.
+ Demonstrated knowledge and interpretation of cGMPs, regulatory guidelines, and regulatory documents such as CFRs, FDA guidance, and ICH guidelines.
+ Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner.
+ Experience in FDA and other regulatory audits.
Additional Skills & Qualifications
+ Experience in budgeting, staffing, and purchasing processes.
+ Ability to lead independent and team-based investigations.
+ Proficiency in evaluating new procedures, software, and equipment.
+ Strong problem-solving abilities and a detail-oriented mindset.
+ Ability to interact with internal and external auditors.
Work Environment
The Quality Control Laboratory at a Pharmaceutical Manufacturer consists of a team of 10-13 people. The QC Lab Manager will oversee the team and day-to-day operations. The role offers first shift with flexible hours. There are opportunities to work with new pharmaceutical products and advance within the lab. The company is growing and recently expanded its space, offering a family-like atmosphere. The team conducts extensive testing on epilepsy treatment drugs, with involvement in both wet and analytical testing. The company has five commercialized products and is expanding into supplements, including melatonin and caffeine energy supplements. The company is focused on treating diseases of the central nervous system and severe allergic reactions, including anaphylaxis.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ...@actalentservices.com ( ...@actalentservices.com) for other accommodation options.