What are the responsibilities and job description for the Quality Control Analyst position at Stefanini North America and APAC?
Details:
Job Description
Stefanini Group is hiring!
Stefanini is looking for Quality Control Analyst in St. Paul, MN
For quick Apply, please reach out to Vipul Bhardwaj - call: 2482638630/ email: vipul.bhardwaj@stefanini.com
Work Hours: M-F (40 hours)
Work Location: St. Paul, MN
Shift: 1st Shift
Conduct specific biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs.
Details:
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
Job Description
Stefanini Group is hiring!
Stefanini is looking for Quality Control Analyst in St. Paul, MN
For quick Apply, please reach out to Vipul Bhardwaj - call: 2482638630/ email: vipul.bhardwaj@stefanini.com
Work Hours: M-F (40 hours)
Work Location: St. Paul, MN
Shift: 1st Shift
Conduct specific biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs.
- Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc.
- Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
- Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
- Complete all testing, including special project / protocol testing in a timely and appropriate manner.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Write exception documents.
- Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
- Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
- May perform equipment maintenance and calibrations as required.
- May perform other duties as assigned.
Details:
- Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years' experience.
- Appropriate additional certifications may be required pursuant to state or federal regulatory requirements.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Computer literate.
- Must be detail oriented, conscientious and have high reading comprehension skills.
- Must have basic understanding of laboratory instrumentation.
- Must be able to communicate effectively with supervisors and peers.
- Must be able to read, write, and converse in English.
- Must be able to navigate, conduct searches, and fill online forms on Personal Computer for the purposes of training, performance management, and self-service applications.
- Must have the ability to navigate electronic mail systems and intranet for communication purposes.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of cGMP manufacturing.
- Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems. Knowledge of basic chemical and biological safety procedures.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must have passion to innovate and drive for solutions.
- Must display personal accountability for results and integrity.
- Must display eagerness to learn and continuously improve.
- Must have uncompromising dedication to quality.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.