Quality Control Manager

Summary/Objective

The role of Quality Control Manager is a diverse, challenging, and rewarding position at Epicur Pharma. It requires experience and knowledge in manufacturing, microbiology, and analytic chemistry; additionally, operating requirements in accordance with cGMP (21 CFR Part 210 and 211).

Salary

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

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

• 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 product.
• Ensure all raw material, intermediate, and finished product testing is tracked and trended.
• Assist in review and disposition of root cause analysis, risk assessments, and investigation involving manufacturing and quality operations.
• Final approval on new and revisions to Master Batch Records.
• Monitor KPIs and identifies CAPA for quality and manufacturing operations.
• 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.
• Oversight of deviation reports, investigations, and CAPA.
• Quality oversight of Stability program, including but not limited to, protocol development and relevant LIMS.
• Participates in Annual Product Reviews providing Quality related data and trend reports.
• 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.

Required Education and Experience

• Minimum of 3 years+ of experience directly managing employees including; hiring, performance management, scheduling and conflict resolution required

• 4 years of experience in Quality Control or Quality Assurance

• Compounding, manufacturing, and/or laboratory experience preferred

• 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.)

• NJ Pharmacy Technician License (may be required upon hire)

• 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
• Time Management
• Problem Solving/Analysis
• Quality
• Results Driven
• Technical Capacity
• Thoroughness

Supervisory Responsibility

This position manages particular employees within the Quality Control Department and is responsible for the performance management and hiring of these employees.

Work Environment

This job operates primarily in a controlled laboratory environment. 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.