Quality Control Analyst II, Release & Stability Testing (3rd Shift - Contract)

Rentschler Biopharma Inc.; United States; On-site; USD 111,750,912 - 131,808,768; Full time

Job summary

Rentschler Biopharma, Inc. in Milford, MA is seeking a Quality Control Analyst II for Release and Stability Testing. You will perform analytical testing, ensure GMP compliance, and collaborate with QC and cross-functional teams to resolve quality issues.

The ideal candidate has a life sciences degree and 3+ years in a cGMP lab, with hands-on experience in Empower chromatography software and analytical methods. On-site position with potential weekend/testing as required.

Qualifications

• Bachelor's Degree in Life Sciences discipline.
• Minimum 3+ years’ experience in a cGMP analytical lab environment.
• Self-starting, motivated, and organized with strong time management and adaptability.

Responsibilities

• Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents.
• Create/revise SOPs, Protocols and Reports.
• Practice safe work habits and adhere to safety procedures and guidelines.
• Perform maintenance and cleaning of laboratory equipment.
• Support SME in OOS/OOT investigations, deviations, change controls, CAPA to prevent non-conformances.
• Update and track metrics for trending and reporting; stability and QC data.
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems.
• Exceptional communication and interpersonal skills.
• Assists in training of new hires and retraining of QC staff.

Skills

cGMP analytical lab

Time management

Communication across diverse groups

Self-starting

Education

Bachelor's Degree in Life Sciences discipline

Tools

HPLC/UPLC/cGE/icIEF

Job description

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals.

As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA.

In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities.

With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

The Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods, stability protocols, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). They work independently with minimal supervision ensuring stability tests are performed promptly within predefined testing windows.

The Quality Control Analyst II, Release and Stability Testing, ensures all work performed strictly adheres to cGMP, SOPs, and protocols. They collaborate with QC team members and cross functional teams for timely resolution of quality issues to achieve project goals. They are responsible for identifying and resolving problems of diverse scope in which analysis of data requires evaluation of identifiable factors based on biochemical knowledge and background.

Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

Duties and Responsibilities

• Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents
• Create/revise SOPs, Protocols and Reports
• Practice safe work habits and adhere to safety procedures and guidelines
• Perform maintenance and cleaning of laboratory equipment
• SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances
• Update and track metrics for trending and reporting; stability and QC analytical data
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
• Exceptional communication and interpersonal skills
• Assists in training of new hires and retraining of QC laboratory staff, as needed
• Performs other duties as assigned

Qualifications

• Bachelor's Degree in Life Sciences discipline
• Minimum 3+ years’ experience in a cGMP analytical lab environment
• Must have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficiently
• Self-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
• Able to use and learn standard office equipment and technology with proficiency
• Experience in Empower chromatography software

Working Conditions

• Laboratory environment working with chemical reagents and analytical equipment
• Normal office working conditions: computer, phone, files, fax, copier
• Personal Protective Equipment must be worn as required
• Minimum travel required
• Work is to be performed on site
• Possible weekend/off hours testing may be required

Physical Requirements

• Frequent standing/walking PPE as required
• Able to work upright and stationary and/or standing for typical working hours
• Able to lift and move objects up to 25 pounds

Base Pay Range

$39/hr - $46/hr

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Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The salary pay range is subject to change and may be modified at any time.

Rentschler Biopharma is a contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. We live by the motto: Many hands, many minds - one team! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents, we pursue one vision together: advancing medicine to save lives.