Quality Control Analyst - Manufacturing at Epicur Pharma – Mount Laurel Township, New Jersey
About This Position
Summary/Objective
The Quality Control Analyst is responsible for ensuring the quality of materials and finished drug products are manufactured to meet current Good Manufacturing Practice (cGMP) and Epicur Pharma standards.
Salary
Starting at $20/hour based on experience plus twice a year bonuses
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Perform quality inspection on incoming materials intended to be used in the manufacturing of drug products.
- Perform in-process quality checks and inspections for finished drug products to ensure standard are met.
- Assist in documenting and maintaining material and product samples (i.e. retains, stability, finished product, etc.)
- Perform logbook reviews for accuracy and good documentation practice.
- Document inspection and testing results by completing QC reports and logs
- Perform random audits of manufacturing operations to ensure activities comply with quality standards and SOPs.
- Participate in the execution/verification of corrective and preventative action (CAPA) and change controls.
- Complete and review batch record documentation for quality release of finished product.
Required Education and Experience
High school diploma or general education degree (GED)
Familiar with cGMP and 21 CFR Part 210 & 211 preferred, but not required
Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles)
Must be able to follow gowning/garbing procedures (cannot wear makeup, must remove jewelry before entering manufacturing area)
Must possess strong verbal, written, and oral communication skills
Must be able to work independently and with a team
Able to recognize priorities and take action; make productive use of time
Must exhibit punctuality and low absenteeism
Able to sit and/or stand 8-10 hours or more per day as needed
May need to lift up to twenty-five (25) pounds on occasion
Competencies
- Communication
- Organizational Skills
- Results Driven
- Technical Capacity
- Thoroughness
Work Environment
This job operates primarily in a controlled manufacturing environment. This position requires the use of standard office equipment and frequent standing/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 be able to interpret instructions furnished in written, oral, and diagram or schedule form, and deal with a variety of concrete variables in situations where substantial standardization exists.
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.
- May need to lift up to twenty-five (25) pounds on occasion
- This position is moderately active and requires standing and walking for a majority of the shift.
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.
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.
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Job Location
Job Location
This job is located in the Mount Laurel Township, New Jersey, 08054, United States region.