Quality Control Manager

Job Description

Lead the Quality Control department in exceptional standards and service for internal and external stakeholders. Maintain the highest standards of GMP and ICH regulations, as well as demonstrate knowledge of HPLC, GC-MS, Sink Dissolution, and Solid-State Characterization. Responsible for leading, managing, and training a team of QC scientists, as well as reporting results and maintaining regular communication with various project stakeholders. Laboratory responsibilities include assisting in QC stability set-up and testing, conducting QC chemical tests per SOPs, operating analytical instrumentation, maintaining a clean and safe work environment in accordance with cGMP standards, reporting regular updates and staying on-track with multiple project priorities. Management responsibilities include frequent reporting with customers and internal stakeholders making strong communication skills essential for this role.

Supervisory Responsibilities:

• Recruits, interviews, hires, and trains new staff.
• Oversees the daily workflow of the department.
• Provides constructive and timely performance evaluations.
• Handles discipline and termination of employees in accordance with company policy.
• Performs other related duties as assigned.

Duties/Responsibilities:

• Lead, manage, and inspire a team of QC Chemists to success.
• Maintain regular communication with internal and external stakeholders to ensure client projects are on track, provide regular team updates to QC Director.
• Act as primary contact point within the QC lab for internal and external clients. Ensure projects within the QC lab remain on track.
• Prepare, manage, and set-up stability testing. Write and maintain stability records and summaries.
• Prepare and conduct various analytical tests in accordance with SOPs.
• Maintain a clean and safe work environment per GMP regulations.
• Keep track of monthly QC supplies, place orders when refills needed.
• Assist in transfer of methods to and from QC.
• Manage multiple competing project priorities and timelines independently.
• Perform minor equipment trouble-shooting and repair.
• Individual contributor at a high-level.
• Promote and maintain a culture of continuous improvement through additional project work.
• Act as group leader within the QC department.
• All other related duties as assigned.

Required Skills/ Abilities:

• Experience with HPLC, GC-MS, Sink Dissolution and Solid-State Characterization.
• Ability to follow SOPs and work efficiently and safely in a GMP regulated work-environment.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent sales and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with Microsoft Office Suite or related software.

Education and Experience:

• Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline.
• Advanced degree or equivalent experience preferred.
• 5-10 years of relevant experience in CDMO laboratory.
• Requires 5 years of GMP experience.