Quality Control Chemist

SPI Pharma, Inc.; Lewes (DE); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

401k match

Job summary

SPI Pharma, Inc. in Lewes, DE, is seeking a Quality Control Chemist to join the Quality Control department. The role supports in-process and finished product testing, ensuring adherence to cGMP and documentation standards.

The candidate will contribute to problem resolution, method development, and data management using LIMS, with occasional travel as needed. Bachelor’s degree in science and 1–3 years of related experience are required.

Qualifications

• Bachelor’s degree in Science field required.
• 1-3 years of relevant pharmaceutical or chemistry experience.
• Experience with cGMP documentation review/approval, release, investigations and training.
• Occasional travel may be required.

Responsibilities

• Test in-process samples and raw materials and report results to production personnel.
• Perform finished product and stability testing as assigned.
• Support site projects with testing as needed.
• Ensure SOPs and cGMP compliance are understood and followed.
• Assist with deviation investigations and drive closure.

Skills

Attention to detail

Interpersonal communication

Team player

Adaptability

Problem analysis

Planning & organization

Independent work

Education

Bachelor’s degree in Science

Tools

LIMS

Job description

Want to start a new career in the exciting field of pharmaceuticals? Are you safety and quality vigilant? Launch a new career with growth opportunities!

SPI Pharma is for you!

SPI Pharma is looking for a Quality Control Chemist to join their team!

401k match of 1:1 for the first 5% contributed plus an additional 5%

Join the small team that is making a big difference!

Who is SPI Pharma?

We are a globally recognized market leader in Pharmaceutical Excipients and Drug Delivery Systems supplying products and formulary solutions to some of the world’s largest pharmaceutical manufacturers.

SPI Pharma is part of Associated British Foods - a diversified international food, ingredients and retail group with annual sales of $20B, 137,000 employees and operations in 50 countries across Europe, southern Africa, the Americas, Asia and Australia.

Quality Control Chemist
Department: Quality Control
Reports To: Quality Control Supervisor
FLSA Status: Non-Exempt
Location: Lewes, DE

Summary

As a team member of the Quality Control group, helps to ensure that the site follows all Federal, State and company mandated quality compliance programs with emphasis on proper current, Good Manufacturing Practices, (cGMP) documentation auditing and testing.

Essential Duties and Responsibilities

• Supports the production of the product by testing in-process samples and raw materials with urgency and report the results and any issues to the appropriate production personnel
• Complete finished product testing and stability testing as assigned
• Complete testing to support site projects as assigned
• Ensure site awareness of quality standard operating procedures (SOP’s) and (cGMP) regulations
• Problem Resolution, method development, instrumental trouble shooting and validation
• Provide a Quality presence in the production area while being the liaison with production employees for (cGMP) compliance; make recommendations for improvements
• Create and/or approve labels after generation and other duties as assigned; maintain (cGMP) compliant documentation and data storage of testing performed
• Review in-process batch record calculations in the absence of QA personnel
• Conduct room and equipment inspections and approve release after production cleaning in the absence of QA personnel
• Properly maintain and file-controlled documents
• Assist with deviation investigations that occur on-shift and drive closure
• Uses Laboratory Information Management Systems (LIMS) to maintain testing results
• Provide backup assistance to other Quality Control personnel as needed
• Assist with collection of data for Regulatory Requests or Annual Product Reviews as applicable, customer compliant investigations as needed, and assist with Assist Quality Control Supervisor/Manager with tasks and projects as needed
• Able to identify basic technical problems and develop solution ideas with the help of supervision
• Ability to perform problem investigations with little to no supervision
• Perform all other duties, as assigned

Education, Skills and Experience

• Bachelor’s degree in Science field required
• 1-3 years of relevant and equivalent work experience work experience within the
  pharmaceutical or chemistry industry.
• Experience with typical Quality projects such as (cGMP) documentation review/approval
  auditing, product and raw material release, change control, investigations, and training.
• Planning and organization: the ability to plan and manage multiple priorities and projects;
• Ability to work with all personnel in a professional and tactful manner and to act
  independently when handling recurring issues.
• Attention to detail.
• Problem analysis and resolution;
• Excellent interpersonal and communication skills;
• Strong team player.
• The ability to learn and adapt quickly to new priorities and or situations.
• Meet project deadlines
• Displays technical commitment and initiative.
• Occasional travel may be required