Senior QC Manager - GMP Lab Leader

ALK-Abello, Inc; Plainville (CT); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

12 holidays per year

Job summary

ALK-Abello, Inc. in Plainville, CT is seeking a experienced QC Manager to lead the quality control team in Chemistry and Microbiology. You will manage daily operations, collaborate across departments, and ensure regulatory compliance in a fast-paced environment.

Responsibilities include document control, budgeting, calibration, audits, and staff training to maintain cGMP standards and quality metrics. A strong chemistry background is essential.

Qualifications

• Minimum 5 years of progressive management experience in a laboratory setting with increasing responsibilities in Pharmaceutical or GMP environment.
• Strong Chemistry knowledge and familiarity with regulatory guidance (cGMP, USP, FDA and ICH).

Responsibilities

• Oversee daily QC operations in Chemistry and Microbiology laboratories, ensuring end-to-end compliance of testing and release.
• Collaborate with other departments to resolve quality-related matters and improve processes.
• Author, edit, review, and approve documents including SOPs, deviations, CAPAs, change controls and monitoring reports.
• Manage QC administration, scheduling, budgeting, and calibration/maintenance of instruments.
• Lead internal and external audits and train QC staff on procedures and protocols.
• Support product validation and stability studies with accurate data reporting.

Skills

Leadership

Quality systems

GxP knowledge

FDA guidelines

Education

BS / BA in life sciences, biology, chemistry or related field

Job description

ALK-Abello, Inc. in Plainville, CT is seeking a experienced QC Manager to lead the quality control team in Chemistry and Microbiology. You will manage daily operations, collaborate across departments, and ensure regulatory compliance in a fast-paced environment.

Responsibilities include document control, budgeting, calibration, audits, and staff training to maintain cGMP standards and quality metrics. A strong chemistry background is essential.