Quality Assurance Manager - Calculated Hire : Job Details

Quality Control Manager

Calculated Hire is working with a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. This opportunity as a QC Manager is full-time and salaried.

SUMMARY:

We are looking for an experienced Quality Control Manager with a strong background in Chemical or Biological Sciences and at least 7 years of experience in a QC laboratory environment. The QC Manager will be responsible for managing laboratory staff, implementing procedures and guidelines, ensuring compliance with regulatory standards, and overseeing various testing processes, including raw materials, in-process, and finished products. This role involves coordinating stability protocols, method transfers, and validations while ensuring accurate data analysis and review. Must be willing and able to work additional hours as needed to meet department and business needs.

Work Schedule: Monday - Friday 8am-5pm

JOB QUALIFICATIONS:

• Bachelors or Master Degree in Chemical or Biological discipline.
• Must have 7+ years experience in Quality Control laboratory environment.
• Knowledgeable in cGMPs, FDA regulations, and FDA Guidance.
• Strong leadership skills and experience required.
• Strong planning and organizational skills, with the ability to manage multiple projects simultaneously.
• Ability to work effectively both independently and in a team/matrix environment.
• Excellent interpersonal skills and the ability to work well in teams.
• Capable of thriving in a fast-paced environment, with strong prioritization skills and the ability to meet multiple deadlines.
• Strong verbal and written communication skills, skills with meticulous attention to detail.
• Proficient in computer applications.
• Must be willing and able to work additional hours as needed to meet department and business needs.

POSITION RESPONSIBILITIES:

• Directly supervises the QC laboratory technical and support staff.
• Manages the development and implementation of goals, objectives, procedures, and systems for the QC laboratory, ensuring compliance with company policies and cGMP standards.
• Establishes and maintains analytical procedures, methods, and guidelines.
• Selects and trains staff on laboratory procedures and equipment usage; assigns tasks and evaluates performance.
• Performs sample analysis using various techniques and instruments, and conducts data reviews as necessary.
• Supervises raw material testing, in-process testing, bulk testing, stability sample testing and finished product testing.
• Supervises and participates in the execution of stability protocols, method transfer and method validations.
• Supervises the development and maintenance of Certificates of Analysis of bulk and finish products.
• Supervises the laboratory equipment calibration program.
• Writes laboratory investigations and recommends corrective and preventative actions.
• Develops, implements, and maintains Standard Operating Procedures (SOPs) related to Quality Control.
• Performs other tasks as directed by the Director of Quality.

PHYSICAL REQUIREMENTS:

• Adhere to all safety policies; includes wearing personal protective equipment when required.
• Light physical activity performing non-strenuous daily activities of an administrative nature.
• Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time.
• Manual dexterity sufficient to reach/handle items and work with the fingers.
• Use of hands to fingers for typing and other computer activity for up to 75% of your time.
• Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time.
• Ability to lift, up to 50lbs, less than 25% of the time.