What are the responsibilities and job description for the Quality Control Analyst II, Release & Stability Testing position at Rentschler?

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. 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. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

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

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Quality Control Analyst II, Raw Material

Rentschler

Milford, MA Full Time

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceutica...

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Quality Control Analyst II, Release & Stability Testing

What are the responsibilities and job description for the Quality Control Analyst II, Release & Stability Testing position at Rentschler?

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Job openings at Rentschler

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