ARD & QC Manager, Laboratory Operations
About The Position
The ARD & QC Manager, Laboratory Operations leads and manages laboratory functions to support operational efficiency and regulatory compliance. The role works cross-functionally with internal departments and external resources on ARD/QC matters and supports compliance with applicable regulatory requirements and company Standard Operating Procedures (SOPs). The manager leads, trains, and mentors quality control scientists; oversees laboratory equipment, software, chemical and consumables inventory, outsourced testing, and EHS activities; and leads internal safety and cGMP self-inspections. The position also maintains and troubleshoots analytical instruments, develops procedures and qualification protocols, and prepares or supports laboratory documentation and investigations. The work is performed in a laboratory and office environment. It typically involves standing and walking for an entire shift, occasional lifting of up to 20 pounds, frequent use of a step stool, and manual dexterity and visual abilities. Occasional work outside normal business hours, including nights, weekends, or holidays, may be needed.
Requirements
- Proficiency with Microsoft Office.
- Knowledge and experience with cGMP, ICH guidelines, USP, and Ph.Eur.
- Hands-on experience with various analytical instruments.
- Excellent verbal and written communication and interpersonal skills.
- Ability to work independently and collaboratively in a team environment with internal and external members.
- Analytical thinking, strong problem-solving skills, and adaptability to changing priorities and deadlines.
- Strong planning, organization, and time-management skills, including the ability to support and prioritize multiple projects.
- Ability to work outside normal business hours, including occasional nights, weekends, or holidays, as needed.
- BS, MS, or PhD in chemistry, biology, biochemistry, or a related discipline.
- At least 6 years of relevant experience with a BS, or at least 4 years with an MS or higher degree, or an equivalent combination of work experience, education, and training.
- At least 3 years of QC laboratory work experience.
Responsibilities
- Perform work safely and compliantly according to EHS best practices and cGMP guidelines.
- Lead, supervise, train, and mentor quality control teams and junior QC and associate scientists.
- Work with management and vendors to acquire, install, and qualify new equipment.
- Serve as the primary contact for negotiating quotes, service agreements, and contracts.
- Manage and schedule work outsourced to third-party analytical and metrology service providers.
- Develop procedures and SOPs for equipment calibration and operational qualification (OQ).
- Develop protocols for software qualification and validation.
- Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
- Manage laboratory chemicals and consumables, including inventory tracking and replenishment.
- Lead internal self-inspections to support safety and cGMP compliance.
- Prepare SOPs, protocols, reports, and other documentation as needed.
- Conduct out-of-specification (OOS), risk assessment, and root cause investigations, or assist management with them.
- Write deviations, change controls, and corrective and preventive actions (CAPAs), or assist management with these documents.
- Document work in laboratory notebooks and logbooks according to organizational GDP policies.
- Manage equipment and software, sample management including outsourced testing, and EHS activities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
