Qc Chemist I
PCI Pharma Services · Bedford, NH · 1 mo ago
Quality AssuranceFull-time
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in people who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Title: QC Chemist I
Location: Bedford, New Hampshire
Department: Quality Control (QC)
Reporting To: Sr. Manager, QC & Analytical Development
Responsibilities
- Perform routine analytical testing of samples supporting incoming raw materials, in‑process production, finished product release, long‑term stability and validation samples.
- Assist in deviation investigation, out‑of‑specification or aberrant results, and process changes.
- Assist in authoring and/or review of GMP documentation including test methods, protocols, reports and raw data.
- Log and track samples and chemicals; order chemicals and laboratory supplies as needed.
- Document and peer‑review laboratory work using laboratory notebooks/worksheets, ensuring detailed, timely compliance with cGMP/GDP requirements.
- May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation.
- Perform routine data generation and problem solving.
- Perform other duties as assigned.
- Assist in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management.
Qualifications
- 0‑3 years relevant analytical chemistry experience, preferably in Quality Control.
- Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a closely related field.
- General knowledge of analytical techniques using instruments such as pH meter, osmometer, density meter, UPLC, HPLC, FTIR, UV/VIS, Karl Fisher, and particle size analyzer.
- Excellent organizational skills and ability to document technical data.
- Excellent interpersonal skills and ability to communicate well orally and in writing to all levels of the organization.
- Ability to multi‑task in a dynamic environment with changing priorities.
- Strong attention to detail, strong problem‑solving skills, and ability to work in a cross‑functional team environment.