Date Posted: 11/18/2024
Hiring Organization: Rose International
Position Number: 474488
Job Title: Quality Control Analyst (Microbiology)
Job Location: Myerstwn, PA, USA, 17067
Work Model: Onsite
Shift: M-F start 7:00am EST
Employment Type: Temporary
Estimated Duration (In months): 13
Min Hourly Rate($): 22.00
Max Hourly Rate($): 26.00
Must Have Skills/Attributes: GMP, Laboratory, Pharmaceutical, Quality Control (QC), Statistics
Job Description
EDUCATION REQUIREMENTS
• Bachelor’s degree in Chemistry, Biology, Pharmacy, or related 4 year science degree required.
REQUIRED SKILLS
• At least 1 year of lab experience is required. Assigned within the Microbiology area and/or previous experience in microbiology processes is preferred.
• Knowledge, practical application, and understanding of microbiology are necessary to perform the functions of this position.
• Good documentation practices
• Ability to work collaboratively in a team-based environment is required.
• Good working knowledge of personal computer skills are required.
• Working knowledge of aseptic techniques, environment monitoring methods, Gram staining and microbiological test methods is required.
• Competencies required: analytical problem solving, work within established policies and procedures, effective written and interpretive communication skills, and organization and planning skills.
PREFERRED SKILLS
• A working knowledge of statistics, data processing and good manufacturing practices is desirable.
• A thorough understanding of National Formulary (NF); United States Pharmacopoeia (USP); and European Pharmacopoeia (EP) testing procedures, as well as, US Pharmaceutical Industry Good Manufacturing Practices (GMP’s), quality control methods and procedures preferred.
POSITION SUMMARY
This position is in the Quality Assurance department and the incumbent will be expected to continuously learn Quality Assurance systems, manufacturing, and effectively engage in relationships with peers in the laboratories, Manufacturing/Production and personnel in other departments as needed. Once the incumbent is assigned specific products on which to perform the quality assurance tests, or provide development or troubleshooting, the incumbent will have considerable impact on results from his/her work. Material can be rejected and manufacturing procedures can be altered significantly either in schedule changes or in process itself. Perform analysis on raw materials, intermediates, purified water systems, environmental monitoring and finished products, following prescribed procedures to provide the information base leading to raw material/intermediates/product disposition. Assist in troubleshooting and problem solving as directed, within the Microbiology area; focus is on Microbiological testing.
RESPONSIBILITIES
• Perform standard qualitative and quantitative analysis on: purchased raw materials, in-process products, pure drug substances and finished pharmaceutical preparations employing standard procedures, in accordance with approved testing procedures of the company, the National Formulary (NF) and the United States Pharmacopoeia (USP).
• Utilize standard "bench" microbiological aseptic technique
• Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms.
• Evaluate all data obtained from analysis; if discrepancy or deviation occurs, consult with Supervisor and recommend additional testing if necessary.
• Adhere to the pertinent aspects of Corporate and plant safety programs and adhering to GMP’s, ISO standards or other regulations.
• Assist in investigating non-compliance investigations.
• Assist with troubleshooting analytical methodology and instrumentation malfunctions.
• Perform special assignments as directed by supervisor.
• Assist in validation of manufacturing and production lines and equipment pertinent to microbiology (e.g. equipment and room cleaning validation).
• Prepare microbiological testing media/diluents.
• Perform testing of water samples from Purified (Reverse Osmosis) Water, USP systems.
• Perform microbiological environmental monitoring in production areas and in the Microbiology Laboratory.
DEPARTMENT/TEAM DESCRIPTION
Microbiology Team working in a fast-paced environment, supporting manufacturing and packaging of OTC Drug and Nutritional products, across multiple shifts, by performing all aspects of Microbiological testing.
***Drug screen & criminal background check will be required
***This Site requires a Pre-Hire Physical, Vision and Hearing baseline tests
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
I have been very pleased with my experience with Rose International. Everyone that I encountered was very helpful and courteous.
Stephanie, Consultant
As a contractor, I have to say that Rose International was by far the best agency I have worked for.
Q'testdalir, Consultant
Any time I did have a question and called, the phone was always answered, and my question/concern was immediately resolved.
Sally, Consultant
My on-boarding with Rose was outstanding. The packets of information, the process, and great attention to detail each person gave me allowed me to get started quickly.I appreciated each person's friendly and helpful attitude.
Diana, Consultant
The interactions that I have had with your representatives have always been prompt and very professional. I am very pleased and impressed with your company and services.
Sioe, Consultant
EMPLOYEE COMMENTS