General information
Company / Establishment
SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients, delivering outstanding performance, unrivalled market responsiveness and tailor-made solutions to our customers.
Our mission is to bring R&D and industrial performance to our clients' projects with our unique skill set and a broad range of technologies.
SEQENS operates 24 manufacturing plants and 10 R&D centers in Europe, North America and Asia with 3,200 employees. More than 300 scientists, engineers and experts develop tailor-made solutions for our customers and ensure that products are successfully transferred into production.
Reference
2022-764
Position description
Job Family / Sub-family
Quality & Regulatory - Quality Control
Contract type
Permanent
Job title
Analyst II, Quality Control M/F/D
Position Context:
Ø Purpose of the position:
QC Senior Analyst is passionate about science and is hands-on. The QC Analyst can build and maintain a top-notch QC department with an error rate of less than 1%.
Main tasks :
Ø Main missions:
· Proactively perform QC function in full compliance with cGMP.
· Schedule workflow and supervise other QC Analysts.
· Oversee and lend support to laboratory personnel in testing raw materials, in-process samples, finished product, and stability samples.
· Troubleshoot, maintain, procure and install various analytical instruments.
· Actively participate on cross functional improvement initiatives.
· Conduct lab Out Of Specification (OOS), Out Of Tolerance (OOT) investigations, and material non-conformance investigations.
· Oversee / conduct the transfer of validated methods from Method Development group to Quality Control laboratory.
· Conduct hands-on training for all QC chemists and technicians.
· Maintain the laboratory in compliance with the company’s cGMP and Environmental Health and Safety (EH&S) procedures.
Required skills :
Bachelor’s Degree in Chemistry or related field
2-5 Experience working in API manufacturing facility, QC testing, Analytical Chemistry testing, and be independent
Ability to operate advanced analytical instrumentation under ICH /GMP guidelines.
Passion, drive, commitment, entrepreneurial orientation and the force of will to persevere until QC function has an error rate of less than 1%.
Content expertise, leadership experience, metrics-orientation, flexibility
Desire to work in a fast-paced, resource-constrained, entrepreneurial, team-oriented growth environment where our goals are ambitious, and our resourcing is leveraged.
Position location
Job location
USA, Massachusetts, Newburyport
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