Quality Assurance Reviewer
Join LLOYD, Inc., a company with new products and opportunities!
A small family owned pharmaceutical company located in a small Midwest town in Iowa, is a well-established manufacturer and marketer of nutritional and pharmaceutical products and employs approximately 95. Operations are currently certified for both animal and human products. This company is located approximately 1 hour from Omaha, NE, and 2 hours from Kansas City, MO.
This full time position comes with a full benefit package after 90 days including health, dental, vision and life insurance. It also comes with a 401K plan, short term & long term disability and a generous PTO plan.
The Quality Assurance Reviewer is responsible for monitoring functions which are mandated by the Food and Drug (FDA) Administration, Good Manufacturing Practices (GMP) and Corporate Operating Procedures (COPs).
Required: High School diploma with preference for at least 2 years of college in physical sciences
Preferred: Associates or BS in Mathematics, Physical Sciences or Biology
Required: A minimum of 3-5 years working experience
Preferred: Quality assurance experience in a drug, medical device or other regulated industry.
C. SKILLS/KNOWLEDGE AND/OR ABILITIES
- Able to follow oral and written instructions
- Must be detail-minded and possess a reasonable degree of manual dexterity
- Must be able to keep accurate, legible records
- Has basic knowledge of manufacturing and packaging.
- Understanding of the flow of materials and products through manufacturing.
- Has knowledge of applicable LLOYD, Inc., manufacturing, Quality Assurance, and Quality Control Standard Operating Procedures
- Has knowledge of cGMP regulations (21 CFR 210 and 211)
Body positions: Sitting and standing
Body movements: Walking; bending at the waist; kneeling down; stooping; turning head and torso; bending and flexing arms, wrists, and fingers; grasping objects in hands; lifting of 15 lb.
Body senses: Must have adequate body senses to perform the requirements of the job
Mathematics: Must be able to understand and perform basic arithmetic computations as demonstrated by successfully passing tests in mathematics; must be able to learn and utilize basic statistical methodologies
Language: Must be able to read, write, and speak English well enough to communicate effectively and to correspond and follow directions precisely
Mechanical: Must be able to handle balances, counting and calibration equipment
Spatial: Must have the ability to observe and notice abnormal physical conditions
Reasoning: Must be able to conduct and interpret various scientific tests and abnormal conditions in records and printed data and labeling
Computers: Must be able to learn to operate a computer, using information management systems and other established programs
F. WORKING CONDITIONS
Most work is performed in an enclosed, environmentally controlled facility. Minimal exposure to chemicals may be necessary when products are sampled.
Has the authority to take action to meet the responsibilities and perform the duties described herein within the limitations established in the COPs, cGMPs, and SOPs. In case of a variance or deviations from normal operating procedures, the reviewer must notify QA Management to conduct an immediate preliminary Variance Investigation
H. GENERAL RESPONSIBILITIES
The Quality Assurance Reviewer is responsible for monitoring functions for which qualifications have been established as designated below in Specific Duties & Tasks
I. SPECIFIC DUTIES AND TASKS
- Release of In-Process and Finished Products
- Reviewing Validation procedures and results in compounding, powder and liquid filling, and tablet compression, filling, and packaging
- Reviewing new equipment and periodic equipment qualifications, including installation, Operation and Process Qualifications
- Completing Quality Control Unit Final Record Review Checklist
- Final Review of all production records
- Performing and evaluating Variance Investigations
- Review stability data generated by Quality Control for submissions
- Review new, revised, and re-printed labeling prior to ordering for use in production labeling operations
- Review new, revised, and re-printed labeling after receipt for use in production labeling operations
- Release of raw materials after Quality Control Testing
- Review of Master Batch Production Orders including: compounding instructions, compression, filling, and labeling
- Completion of the Annual Drug Product reviews
- Generate Certificate of Manufacture for export products, if required
J. OTHER CRITERIA
- Seek guidance and direction as necessary for the duties performed
- Make the best use of time during the shift
- Provide proper advance notice of absence
- Assume responsibility for staying aware of policy or procedure changes
K. MEASURES OF PERFORMANCE
- Timely completion of work assignments
- Accuracy and completeness of work performed
- Neatness and cleanliness of work area
- Proper maintenance of technical equipment and instruments
- Cooperation and promotion of teamwork within the QAU and between Quality Control and Production Departments