Associate, Quality Control - Temporary Maternity Leave Replacement

Alfasigma; Town of Italy (NY); Hybrid; USD 52.000 - 75.000; Vollzeit

Zusammenfassung

Alfasigma is seeking an Associate, Quality Control on a temporary maternity leave replacement to support routine testing of raw materials and finished products to ensure timely release in compliance with cGMP and regulatory standards.

Under supervision, you will perform tests, record data, maintain GDP documentation, and assist with laboratory operations while collaborating with cross-functional teams to sustain quality and product continuity.

Qualifikationen

• Bachelor's degree in Chemistry, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, or related science.
• Basic knowledge of pharmaceutical analytical testing techniques.
• Familiarity with regulated pharma environments is a plus.
• Proficient in data recording and GDP practices.

Aufgaben

• Perform routine testing of materials and finished products using approved methods.
• Record results and maintain GDP-compliant documentation.
• Support laboratory operations and sample management under supervision.
• Ensure compliance with FDA/cGMP requirements and SOPs.
• Collaborate with QA and cross-functional teams to meet timelines.

Kenntnisse

Laboratory testing

cGMP awareness

Documentation (GDP)

Analytical instrumentation

English communication

Ausbildung

Bachelor's Degree in Chemistry or related field

Tools

Laboratory Information Systems (LIMS)

Microsoft Office

Jobbeschreibung

Select how often (in days) to receive an alert:

Associate, Quality Control - Temporary Maternity Leave Replacement

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

Scope of the Role

The Associate, Quality Control is responsible for supporting routine laboratory testing activities to ensure the timely release of raw materials and finished products in compliance with cGMP requirements, internal procedures, and regulatory standards. Working under supervision, the role contributes to maintaining laboratory performance and supporting business continuity through accurate testing, documentation, and adherence to quality standards.

This position is offered as a temporary maternity leave replacement.

Your Role

• Perform routine testing of raw materials, in-process materials, and finished products following approved analytical methods and procedures.
• Support the analysis of customer and production samples using standard laboratory instrumentation.
• Ensure compliance with FDA regulations, cGMP requirements, and internal Standard Operating Procedures (SOPs).
• Operate laboratory equipment and perform basic maintenance activities as required.
• Accurately record test results and laboratory data in accordance with Good Documentation Practices (GDP).
• Assist with daily laboratory operations and sample management activities under appropriate supervision.
• Follow written analytical methods, protocols, and verbal instructions accurately and consistently.
• Support investigations related to laboratory activities when required.
• Maintain laboratory cleanliness, organization, and compliance with safety procedures.
• Collaborate with Quality Control colleagues and cross-functional teams to ensure timely completion of laboratory activities.

Who you are

Education

• Bachelor's Degree or equivalent qualification in: Chemistry, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Pharmaceutical Sciences or Other relevant scientific disciplines

Experience and Technical Skills

• Basic knowledge of pharmaceutical and analytical testing techniques.
• Familiarity with laboratory operations within a regulated pharmaceutical environment is considered an advantage.
• Ability to operate standard laboratory equipment and perform routine maintenance activities.
• Understanding of cGMP principles and quality requirements.
• Ability to execute laboratory methods and procedures accurately.
• Basic knowledge of data recording and documentation practices.
• Proficiency in Microsoft Office applications and laboratory information systems is considered a plus.
• Good written and verbal communication skills in English.
• Attention to detail and accuracy.
• Strong organizational and time management skills.
• Ability to learn quickly and follow established procedures.
• Team-oriented mindset and willingness to collaborate.
• Commitment to quality, compliance, and safety.
• Ability to work effectively under supervision while managing routine activities.
• Problem-solving attitude and willingness to continuously develop technical skills.

The compensation range indicated in this job posting represents an estimated average range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.