Manufacturing Specialist
The University of Iowa
Iowa City, IA
Full-time
Manufacturing / Production / Operations
Posted on February 25, 2019
Pharmaceutical Manufacturing Specialist Summary:
In compliance with FDA and EMA regulations, the Pharmaceutical Manufacturing Specialist completes and coordinates quality assurance activities within the Inspection, Labeling and Control (ILC) unit of UIP to support the pharmaceutical manufacturing of various dosage forms.
Job Duties:
• Document procedures according to established regulatory guidelines.
• Follow regulations and procedures for handling hazardous/regulated chemicals.
• Complete and pass product qualifications prior to inspections of various product forms.
• Participate in equipment validations.
• Confirm compliance with standard operating & safety procedures during all manufacturing phases of the project.
• Prepare or revise standard operating procedures for new or existing equipment and processes.
• Count, wipe, inspect, label, package, and store finished product following batch record and SOP requirements for various product forms.
• Use software (i.e. word processing, spreadsheets, database, email, and equipment operating/data collection software) relevant to manufacturing duties.
• Setup, operate, clean, and mainta in ILC equipment following standard operating procedures.
• Enter data in project batch records and gather other data as needed to complete related reports.
• Assist with the disposal of unused finished products, rejected products, remaining solutions, and other miscellaneous products.
• Assist with packaging of product for shipping and preparation of all necessary documentation as directed.
University of Iowa Pharmaceuticals (UIP), located within the College of Pharmacy, provides contract pharmaceutical services including pharmaceutical development, manufacturing, and testing. UIP can support the manufacturing and testing of both clinical and commercial finished products. UIP is a Food and Drug Administration-registered pharmaceutical manufacturing facility, providing expert pharmaceutical development services to clients around the world.
Successful candidates will be subject to a credential and criminal background check.
Five professional references may be requested and required at a later step in the recruitment process.
Required Education:
Bachelor’s degree or equivalent combination of education and experience.
Required Qualifications:
• Effective communication (written and verbal).
• History of collaboration and embracing diversity, positive impact/achieving results, service excellence/customer focus.
• Working proficiency revising electronic word processing and spreadsheet documents.
• Proven attention to detail and ability to follow lengthy procedures.
Highly Desirable Experience:
• Experience working in quality control, inspections, or a regulated industry.
Desirable Experience:
• Experience in a manufacturing environment.
• Experience with Standard Operating Procedures.
• Experience setting up, operating, performing preventive maintenance, and troubleshooting equipment.
• Knowledge and experience handling hazardous substances.
The university is located along the picturesque Iowa River in Iowa City, a city of some 77,000 people (170,000+ in the metro area) regularly ranked as one of the nation’s best places to live. Iowa City is less than four hours from Chicago and within five hours of Minneapolis, St. Louis, and Kansas City, readily accessible via interstate highways and a regional airport 30 minutes away.
A resume and cover letter are required as part of the application process. Job openings are posted for a minimum of 14 for calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended.
The purpose of the cover letter is to demonstrate effective written communication skills and attention to detail.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.
In compliance with FDA and EMA regulations, the Pharmaceutical Manufacturing Specialist completes and coordinates quality assurance activities within the Inspection, Labeling and Control (ILC) unit of UIP to support the pharmaceutical manufacturing of various dosage forms.
Job Duties:
• Document procedures according to established regulatory guidelines.
• Follow regulations and procedures for handling hazardous/regulated chemicals.
• Complete and pass product qualifications prior to inspections of various product forms.
• Participate in equipment validations.
• Confirm compliance with standard operating & safety procedures during all manufacturing phases of the project.
• Prepare or revise standard operating procedures for new or existing equipment and processes.
• Count, wipe, inspect, label, package, and store finished product following batch record and SOP requirements for various product forms.
• Use software (i.e. word processing, spreadsheets, database, email, and equipment operating/data collection software) relevant to manufacturing duties.
• Setup, operate, clean, and mainta in ILC equipment following standard operating procedures.
• Enter data in project batch records and gather other data as needed to complete related reports.
• Assist with the disposal of unused finished products, rejected products, remaining solutions, and other miscellaneous products.
• Assist with packaging of product for shipping and preparation of all necessary documentation as directed.
University of Iowa Pharmaceuticals (UIP), located within the College of Pharmacy, provides contract pharmaceutical services including pharmaceutical development, manufacturing, and testing. UIP can support the manufacturing and testing of both clinical and commercial finished products. UIP is a Food and Drug Administration-registered pharmaceutical manufacturing facility, providing expert pharmaceutical development services to clients around the world.
Successful candidates will be subject to a credential and criminal background check.
Five professional references may be requested and required at a later step in the recruitment process.
Required Education:
Bachelor’s degree or equivalent combination of education and experience.
Required Qualifications:
• Effective communication (written and verbal).
• History of collaboration and embracing diversity, positive impact/achieving results, service excellence/customer focus.
• Working proficiency revising electronic word processing and spreadsheet documents.
• Proven attention to detail and ability to follow lengthy procedures.
Highly Desirable Experience:
• Experience working in quality control, inspections, or a regulated industry.
Desirable Experience:
• Experience in a manufacturing environment.
• Experience with Standard Operating Procedures.
• Experience setting up, operating, performing preventive maintenance, and troubleshooting equipment.
• Knowledge and experience handling hazardous substances.
The university is located along the picturesque Iowa River in Iowa City, a city of some 77,000 people (170,000+ in the metro area) regularly ranked as one of the nation’s best places to live. Iowa City is less than four hours from Chicago and within five hours of Minneapolis, St. Louis, and Kansas City, readily accessible via interstate highways and a regional airport 30 minutes away.
A resume and cover letter are required as part of the application process. Job openings are posted for a minimum of 14 for calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended.
The purpose of the cover letter is to demonstrate effective written communication skills and attention to detail.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.