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Quality Control Manager
Actalent • Azusa, CA 91702 • Posted 10 days ago
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In-person • Full-time • Mid Level Manager
Job Highlights
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The Quality Control Manager at Actalent is responsible for developing SOPs, guidelines, protocols, and reports to meet GMP and regulatory requirements. This role involves managing method development, validation, raw material and finished product testing, and ensuring compliance with USP, FDA, and other regulatory bodies. The manager will also oversee staff training, budget management, and maintain quality systems. This is a permanent, on-site position in Azusa, California, requiring a laboratory environment setting.
Responsibilities
- Develop SOPs, guidelines, protocols, and reports that meet the requirements of GMP and appropriate regulations.
- Develop and validate microbiological and analytical methods for testing raw material and formulated OTC, personal care, and cosmetic products.
- Manage the day-to-day activities for all method development, transfer, validation, raw material, Bulk, and finished product testing.
- Manage raw material supplier certificate of analysis qualification.
- Manage OTC drug stability program per CHPA and ICH guidelines.
- Assist with performing installation qualification, operational and performance qualification for new instrumentation.
- Spearhead both short- and long-term strategic planning for lab space, infrastructure, and data accessibility/integrity.
- Facilitate the evaluation of new testing applications and instrumentation, including assisting in the purchase and commission of analytical instrumentation.
- Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
- Stay current on publications released by USP, FDA, and other pertinent regulating bodies.
- Formulate a comprehensive lab contract service strategy and establish agreements with third-party laboratories.
- Manage budgets for service contracts, repairs, and equipment maintenance.
- Oversee asset life-cycle management with attention to budget efficiency.
- Conduct thorough staff training and ensure the certification of competency.
- Supervise work processes to guarantee precision and efficiency.
- Ensure meticulous handling of testing samples from receipt to organization and preparation.
- Address initial troubleshooting of testing issues and report problems promptly to leadership.
- Responsible for investigating and processing Deviations, Out-of-Specifications, Out-of-Trend, and QC events.
- Manage the release of raw materials, bulk and finished products according to the appropriate regulations and company policies and procedures.
Qualifications
Required
- HPLC
- Chemistry
- Quality Control
- Personal Care/OTC Products
- Leadership
- Problem-solving
- Strategic planning
- Communication
- Supervisory
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions, connecting companies with experts in various industries. They offer a wide range of engineering and sciences services, tailored to meet each client's unique needs, in industries like aerospace, defense, consumer products, life sciences, transportation, utilities, and construction. Actalent believes in the power of people and focuses on diversity, equity, and inclusion while providing rewarding career opportunities.
Full Job Description
Job Title: Quality Control ManagerJob Description
Develop SOPs, guidelines, protocols, and reports that meet the requirements of GMP and appropriate regulations. Develop and validate microbiological and analytical methods for testing raw material and formulated OTC, personal care, and cosmetic products. Manage the day-to-day activities for all method development, transfer, validation, raw material, Bulk, and finished product testing. Manage raw material supplier certificate of analysis qualification. Manage OTC drug stability program per CHPA and ICH guidelines. Assist with performing installation qualification, operational and performance qualification for new instrumentation. Spearhead both short- and long-term strategic planning for lab space, infrastructure, and data accessibility/integrity. Facilitate the evaluation of new testing applications and instrumentation, including assisting in the purchase and commission of analytical instrumentation. Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples. Stay current on publications released by USP, FDA, and other pertinent regulating bodies to ensure activities throughout the facility are compliant and continuously improved upon. Formulate a comprehensive lab contract service strategy and establish agreements with third-party laboratories to conduct required testing not performed in-house. Manage budgets for service contracts, repairs, and equipment maintenance. Implement efficient planning and scheduling to minimize equipment disruption. Oversee asset life-cycle management with attention to budget efficiency. Conduct thorough staff training and ensure the certification of competency. Supervise work processes to guarantee precision and efficiency. Ensure meticulous handling of testing samples from receipt to organization and preparation. Address initial troubleshooting of testing issues and report problems promptly to leadership. Responsible for investigating and processing Deviations, Out-of-Specifications, Out-of-Trend, and QC events. Possess a deep understanding of ISO standards, Good Lab Practices, 21 CFR, US FDA guidance, and ISO. Ensure compliance with all requirements related to manufacturing, packaging, labeling, and distribution of finished OTC drug products. Establish and ensure quality systems are maintained and function properly. Monitor ongoing quality issues, determine needed changes, and drive the prevention of any new quality issues. Provide supervision and leadership for lab personnel and carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Ensure the laboratory team maintains the appropriate level of accountability for quality decisions. Make fact-based, scientifically sound quality decisions regarding products manufactured based on cGMP and applicable regulatory/industry guidance. Manage the release of raw materials, bulk and finished products according to the appropriate regulations and company policies and procedures. Lead and/or support investigations, authoring, approving, and/or reviewing deviations, OOS and investigation reports and ensuring on-time completion of all corrective action items. Oversight of creating, approving, and maintaining all applicable SOPs.
Hard Skills
+ HPLC
+ Chemistry
+ Quality Control
+ Personal Care/OTC Products
Soft Skills
+ Leadership
+ Problem-solving
+ Strategic planning
+ Communication
+ Supervisory
Job Type
This is a permanent position.
Work Site
This is a fully on-site position in Azusa, California.
Work Environment
Laboratory environment, Monday-Friday, 1st Shift, 6:00am-2:30pm, Some overtime and weekends as needed, Dress Code: Close-toed shoes, no jewelry
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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Develop SOPs, guidelines, protocols, and reports that meet the requirements of GMP and appropriate regulations. Develop and validate microbiological and analytical methods for testing raw material and formulated OTC, personal care, and cosmetic products. Manage the day-to-day activities for all method development, transfer, validation, raw material, Bulk, and finished product testing. Manage raw material supplier certificate of analysis qualification. Manage OTC drug stability program per CHPA and ICH guidelines. Assist with performing installation qualification, operational and performance qualification for new instrumentation. Spearhead both short- and long-term strategic planning for lab space, infrastructure, and data accessibility/integrity. Facilitate the evaluation of new testing applications and instrumentation, including assisting in the purchase and commission of analytical instrumentation. Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples. Stay current on publications released by USP, FDA, and other pertinent regulating bodies to ensure activities throughout the facility are compliant and continuously improved upon. Formulate a comprehensive lab contract service strategy and establish agreements with third-party laboratories to conduct required testing not performed in-house. Manage budgets for service contracts, repairs, and equipment maintenance. Implement efficient planning and scheduling to minimize equipment disruption. Oversee asset life-cycle management with attention to budget efficiency. Conduct thorough staff training and ensure the certification of competency. Supervise work processes to guarantee precision and efficiency. Ensure meticulous handling of testing samples from receipt to organization and preparation. Address initial troubleshooting of testing issues and report problems promptly to leadership. Responsible for investigating and processing Deviations, Out-of-Specifications, Out-of-Trend, and QC events. Possess a deep understanding of ISO standards, Good Lab Practices, 21 CFR, US FDA guidance, and ISO. Ensure compliance with all requirements related to manufacturing, packaging, labeling, and distribution of finished OTC drug products. Establish and ensure quality systems are maintained and function properly. Monitor ongoing quality issues, determine needed changes, and drive the prevention of any new quality issues. Provide supervision and leadership for lab personnel and carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Ensure the laboratory team maintains the appropriate level of accountability for quality decisions. Make fact-based, scientifically sound quality decisions regarding products manufactured based on cGMP and applicable regulatory/industry guidance. Manage the release of raw materials, bulk and finished products according to the appropriate regulations and company policies and procedures. Lead and/or support investigations, authoring, approving, and/or reviewing deviations, OOS and investigation reports and ensuring on-time completion of all corrective action items. Oversight of creating, approving, and maintaining all applicable SOPs.
Hard Skills
+ HPLC
+ Chemistry
+ Quality Control
+ Personal Care/OTC Products
Soft Skills
+ Leadership
+ Problem-solving
+ Strategic planning
+ Communication
+ Supervisory
Job Type
This is a permanent position.
Work Site
This is a fully on-site position in Azusa, California.
Work Environment
Laboratory environment, Monday-Friday, 1st Shift, 6:00am-2:30pm, Some overtime and weekends as needed, Dress Code: Close-toed shoes, no jewelry
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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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