Quality Control Analyst

Mallinckrodt Pharmaceuticals; Madison (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Control (QC) Analyst in Madison to ensure product quality and compliance through testing and analysis of samples and raw materials. The role involves following established test methods, adhering to cGMP practices, and collaborating with a dynamic QC team. Ideal candidates will have a scientific background and experience in laboratory testing methods such as ELISA and PCR, along with strong attention to detail and communication skills.

Qualifications

• Minimum of three years relevant experience.
• Knowledge of cGMP and general chemical/bioanalytical test methods.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Conduct daily analysis of in-process samples, finished products, and raw materials.
• Document and investigate out-of-specification (OOS) results.
• Assist with calibrating and maintaining laboratory equipment.

Skills

Attention to detail

Strong communication

Organizational skills

Education

Bachelor’s degree in a scientific discipline

Tools

ELISA

PCR

UV/Vis spectroscopy

Aseptic technique

Job description

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty pharmaceutical company focused on our mission:Managing Complexity. Improving Lives.We provide medicines to address unmet patient needs, stemming from 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future.

What We Do:

Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients. Mallinckrodt’s growing portfolio of specialty pharmaceuticals help treat a wide variety of health conditions. We invest in areas such as autoimmune and rare diseases; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products. To see what sets Mallinckrodt apart, take a look at our distinctive approach to solving complex challenges with unique solutions.

What We Believe In:

People throughout the world count on Mallinckrodt products every day to help them lead healthier lives. That’s why we proudly stand by the three values we have held for 150 years: to producequalityproducts with the utmostintegrityand unparalleledservicein order to better serve the patients, customers and communities in which we live and work. Explore the roles of our dedicated employees and our commitment to responsibility.

At Mallinckrodt Pharmaceuticals, our five Cultural Hallmarks guide our work and serve as a foundation for our success. Employees are Accountable, Competitive, Collaborative, High Performing and Trustworthy.Our Culture

• ACCOUNTABLE- We are each personally responsibility for ensuring Mallinckrodt's success
• COMPETITIVE- We value breakthrough thinking that leads to industry leadership
• COLLABORATIVE- We work together to create solutions
• HIGH PERFORMING- We deliver on our commitments
• TRUSTWORTHY- We consistently model our values

Job Description

The Quality Control (QC) Analyst will work both independently and within a team to perform daily analysis of in-process samples, finished product and raw materials via established test methods while following cGMP and GDP in the QC laboratory. Typical analysis consists of pH, Osmolality, ELISA, PCR, sterility, UV/Vis spectroscopy and other general chemical and bioanalytical assays.

• Conducts routine analysis of in-process samples, finished products, and raw materials according to standard operating procedures (SOPs) and Master Specifications.
• Utilizes proper aseptic technique during the execution of analysis.
• Performs stability testing according to established schedules.
• Documents and investigates any OOS results.
• Follows cGMP and GDP to perform all tasks.
• Documents and assesses data against established specifications.
• Perform inventory, stock and clean QC laboratories.
• Perform QC review of data records.
• Assist with calibrating and maintaining laboratory equipment.
• May perform training of new and existing QC team on established methods and procedures
• May provide technical expertise for method optimization, verification, qualification, and validation.
• May develop and qualify testing methods and SOPs.
• May assist with or lead QC projects for process improvements.
• May draft reports, plans and protocols.
• May revise and updates SOPs.
• Additional duties as assigned.

Qualifications

Experience / Skills:

• Bachelor’s degree in a scientific discipline or equivalent and a minimum of three years’ related experience required.
• Knowledge of cGMP is required.
• Must possess skills and knowledge of general chemical and bioanalytical test methods.
• Knowledge of ELISA, PCR, UV/Vis spectroscopy, cell culture and aseptic technique is preferred.
• Attention to detail: able to organize and maintain data and information.
• Ability to work in a controlled environment with gowning/PPE requirements.
• Ability to learn through observation and hand’s on experience.
• Ability to work independently in a fast-paced, team oriented organization.
• Strong written and verbal communication skills.

Additional Information

Organizational Relationship/Scope:

• Reports to Quality Control leadership team.
• Work is performed within a team of QC Analysts.
• Regular communication with QC, manufacturing, technical operations among others.

Working Conditions:

• 70% laboratory and manufacturing environment
• 30% normal office and meeting room conditions
• Must be able to perform work while aseptically gowned with the appropriate PPE

All your information will be kept confidential according to EEO guidelines.