QC Manager - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a QC Manager in Anaheim, CA who possesses:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related technical field; must be able to pass education verification
- 5 to 7 years of progressive experience in Quality Assurance or Quality Control, including at least 3 years in a managerial role
- Experience in a cGMP-compliant environment; personal care, cosmetics, or OTC manufacturing experience strongly preferred
- Deep understanding of FDA regulations, including 21 CFR 210/211, ISO 22716, GMP for cosmetics, and related quality standards
Email resumes to [email protected] or call 858.496.7758.
FULL DESCRIPTION: We are seeking a QC Manager to oversee Quality Assurance and Quality Control functions across manufacturing activities. This role is responsible for ensuring products meet internal specifications, customer requirements, and regulatory standards while leading the implementation and continuous improvement of the Quality Management System. The ideal candidate will have strong QA/QC leadership experience, cGMP experience, knowledge of FDA and ISO quality standards, and the ability to lead quality staff in a fast-paced manufacturing environment.
The selected candidate will be responsible for:
- Leading QA and QC teams, including training, development, and performance management
- Developing, implementing, and maintaining a robust Quality Management System in compliance with GMP, FDA, ISO 22716, and customer standards
- Overseeing quality-related activities, including raw material testing, in-process checks, customer component AQL, finished goods inspection, and batch record review
- Investigating and resolving quality issues, including non-conformances, deviations, customer complaints, CAPAs, and root cause analyses
- Ensuring timely review and approval of production and laboratory documentation to support product release
- Managing internal audits
- Coordinating external audits, including customer and regulatory audits
- Ensuring timely resolution of audit findings
- Partnering with R&D, Regulatory, Production, and Supply Chain to support product development, scale-up, and commercialization
- Maintaining and reporting quality metrics and KPIs
- Driving continuous improvement initiatives
- Ensuring calibration and maintenance of laboratory equipment
- Overseeing environmental monitoring and cleaning validation, if applicable
- Staying current with changes in regulatory requirements
- Ensuring ongoing company compliance with applicable quality and regulatory standards
- Performing other duties as assigned
The selected candidate will also possess:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related technical field required
- Must be able to pass education verification
- 5 to 7 years of progressive experience in Quality Assurance or Quality Control required
- At least 3 years of managerial experience required
- Experience in a cGMP-compliant environment required
- Personal care, cosmetics, or OTC manufacturing experience strongly preferred
- Deep understanding of FDA regulations, including 21 CFR 210/211, required
- Knowledge of ISO 22716, GMP for cosmetics, and related quality standards required
- Strong leadership skills
- Strong problem-solving skills
- Strong written and verbal communication skills
- Experience with QMS platforms, LIMS, and document control systems preferred
- Ability to manage multiple priorities in a fast-paced, deadline-driven environment
- Ability to support audits, investigations, CAPAs, deviations, and root cause analysis
- Ability to work collaboratively with R&D, Regulatory, Production, and Supply Chain teams
- Ability to work onsite in Anaheim, CA
Physical Requirements:
- Ability to sit, stand, walk, bend, reach, and move throughout office, laboratory, quality, and manufacturing areas during the workday
- Ability to communicate by phone, email, video meeting, and in person throughout the workday
- Ability to review batch records, quality documentation, audit records, SOPs, regulatory standards, reports, and computer screens for extended periods
- Ability to use hands and fingers for typing, documentation, data review, laboratory record review, and standard office or quality tasks
- Ability to occasionally lift, carry, or move standard office, laboratory, or quality materials as needed
- Ability to work in manufacturing, quality, or laboratory-adjacent environments while following applicable safety, quality, and cGMP procedures
- Ability to wear required personal protective equipment as needed
Salary Range: $140,000/year
For immediate and confidential consideration, please email your resume to [email protected] or call 858.496.7758.
More information can be found at www.simplybiotech.com.
Pay: $140,000.00 per year
Work Location: In person
