Quality Control Manager

Job Description

Job Description

Summary/Objective

The Quality Control (QC) Manager is responsible for overseeing all Quality Control operations and in-process quality activities associated with the manufacturing of drug products at Epicur Pharma. This position requires experience and knowledge in manufacturing, microbiology, and analytic chemistry; additionally, operating requirements in accordance with cGMP (21 CFR Part 210 and 211). This role ensures testing activities are performed in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, USP standards, and company quality systems. The QC Manager manages laboratory personnel, oversees testing operations, ensures timely release of analytical data, supports investigations, and drives continuous improvement initiatives while maintaining the highest standards of product quality and regulatory compliance. 

Salary

$75K based on experience plus twice a year bonuses. 

Essential Duties and Responsibilities  include the following. Other duties may be assigned. 

• Familiar with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) 
• Leads, mentors, and develops employees within Quality Control Department. 
• Dispositions and approves quality testing/inspection of incoming components, raw materials, finished product, and stability sample. 
• Leads development of sampling protocols for in-process materials and finished products. 
• Oversee the testing of raw materials, Active Pharmaceutical Ingredients (APIs), Components, In-process samples and Finished products. 
• Manage the visual inspection program. 
• Assist in review and disposition of root cause analysis, risk assessments, and investigation involving manufacturing and quality operations. 
• Monitor KPIs and identifies CAPA for quality functions. 
• Conduct and review internal audits of processes, systems, and procedures. 
• Provide leadership across functional groups to resolve issues relating to product or production quality. 
• Oversight of method validations for chemistry and microbiology testing methods.
• Participation in deviation reports, investigations, and CAPA. 
• Participates in Annual Product Reviews providing Quality related data and trend reports. 
• QC review of executed batch record and release of finished drug products. 
• Research current Quality/Regulatory requirements, as applicable, and leads SOP implementation/revision to assure compliance and continuous improvement of the overall operation. 
• Ensure all Quality related documents generated at the facility are received by document control at the appropriate time per procedure. 
• Oversees programs are established maintained for respirator fit test and respirator use protocols to ensure safety of employees and conformance with OSHA and NIOSH regulations. 

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Required Education and Experience

• Bachelor’s degree in Biology, Microbiology, Biochemistry, Biotechnology or Chemistry
• 3+ years of experience directly managing employees including; hiring, performance management, scheduling and conflict resolution required 
• 3-5 years of experience in years of experience in the pharmaceutical industry in drug substance or drug product manufacturing in Quality Control or Quality Assurance 
• Workplace Safety experience a plus  Strong organizational, problem solving, analytical, and management skills Familiar with GxP, FDA, ICH, and OSHA requirements
• Familiar with Microsoft Office applications (Word, Excel, etc.)  Must be capable of wearing all protective wear as required. This includes, but not limited to, mask, gloves, gown, hairnet, safety goggles, etc. 
• Must have strong organizational skills and exceptional attention to detail 
• Must exhibit punctuality and low absenteeism
• Able to work independently and as part of a team 
• Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time 
• May need to lift up to twenty-five (25) pounds on occasion

Competencies

• Communication Proficiency
• Decision Making
• Detail Oriented
• Leadership Skills
• cGMP Manufacturing 
• Problem Solving/Analysis
• Project Management 
• Results Driven
• Technical Capacity
• Innovation 

Supervisory Responsibility

This position has supervisory responsibilities for the Quality Control Department

Work Environment

This job operates in both office/shared, controlled manufacturing environments and laboratory testing environments. This position requires the use of standard office equipment, and frequent standing and walking.

Language Skills

Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.

Mathematical Skills

Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability

Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• Able to sit and/or stand 8-10 hours or more per day as needed
• May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed
• Finger dexterity to operate office equipment required
• Ability to lift up to twenty-five (25) pounds on occasion

Position Type and Expected Hours of Work

This is a full-time position. Because of the nature of the business, work schedules may vary at times.

Travel

No travel is expected for this position.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.

AAP/EEO Statement

Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.