Manager, Quality Control

Curia • Rensselaer, NY

21d • $106,000 - $134,000

About The Position

The Manager, Quality Control oversees the site's Quality Control function and a broad range of activities to ensure compliance with applicable regulatory requirements. The role includes conducting and overseeing testing, trending, continuous improvement, and reporting results for samples and incoming, in-process, and final products. The manager leads QC analysts and technicians, organizes work across concurrent projects, supports pharmaceutical analysis, and maintains laboratory safety, inspection readiness, and adherence to company and governmental standards, procedures, and cGMP requirements.

The position is based in Rensselaer, New York, on the night shift. It includes responsibility for customer requests related to QC; schedule adherence and right-first-time performance; shift huddles and shift handoffs; and QC investigations, including out-of-specification results, deviations, change controls, and CAPAs. The manager also mentors and trains team members on applicable techniques and equipment.

Requirements

• Bachelor's degree in Chemistry, Analytical Chemistry, or a related field.
• 5–8 years of experience in a GMP or GLP environment working with chromatography (HPLC/UPLC/GC), including extensive method development and/or validation.
• At least 2 years of professional management experience.
• Experience playing a key role in regulatory inspections.
• Ability to recognize what needs to be done, take action, and accomplish results.
• Strong oral and written communication skills, including effective listening.
• Demonstrated ability to effectively utilize team resources.
• Expert knowledge of cGMP, USP, EP, and FDA regulations.
• Technical competence in understanding the theory and interpretation of laboratory techniques.
• Proficiency with computer software, including Microsoft Office Suite (Excel and Word) and other required software.
• Strong organizational skills and ability to multitask.
• Proficiency in HPLC and GC method development and validation, with extensive experience using other analytical techniques and equipment.
• Prior experience and knowledge of FDA GMPs (21 CFR, 211, 820, and/or 600), ISO 9001, and ISO 13485.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening.

Nice To Haves

• Advanced degree in Chemistry, Analytical Chemistry, or a related field.

Responsibilities

• Manage and prioritize Quality Control testing and operations for samples and incoming, in-process, and final products.
• Ensure QC functions meet company and governmental safety and quality standards and that experimental documentation is complete and timely.
• Supervise analysts and technicians, including their motivation, education, efficiency, performance management, and productivity.
• Ensure laboratory operations are conducted safely, remain familiar with the Chemical Hygiene Plan, and follow safety rules.
• Maintain compliance with applicable regulations, standard operating procedures, and cGMPs.
• Organize workload and coordinate multiple concurrent projects in line with objectives, timelines, and deadlines.
• Drive schedule adherence and right-first-time performance with supervisors and analysts.
• Maintain laboratory inspection readiness.
• Handle customer requests related to QC items.
• Ensure the team initiates deviations and completes investigations and extensions to maintain regulatory compliance.
• Ensure supervisors follow supervisor standard work for shift huddles and establish a shift handoff process for QC operations.
• Manage QC investigations involving out-of-specification results, deviations, change control, and CAPAs.
• Oversee and perform pharmaceutical analysis to support operations.
• Mentor and train team members on applicable techniques and equipment.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager