QC Chemist I

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 55,000 - 75,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QC Chemist I to support the Quality Control laboratory. You will test samples from raw materials through finished products and stability studies, under cGMP guidelines.

You will assist with validations, method qualifications, and documentation, working with cross-functional teams to ensure accurate data and timely reporting.

Qualifications

• Required: 0-3 years relevant Analytical Chemistry experience, preferably in Quality Control.
• Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or closely related area.
• General knowledge of analytical techniques using instruments such as pH Meter, Osmometer, Density Meter, UPLC, HPLC, FTIR, UV/VIS, Karl Fischer, Particle Size Analyzer.
• Excellent organizational skills and ability to document technical data.
• Excellent interpersonal skills and the ability to communicate well orally and in writing to all levels of the organization.

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.
• Logging and tracking of samples and chemicals. Order chemicals and laboratory supplies as needed. Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely and in 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. Performs routine data generation and problem solving.

Skills

Analytical Chemistry

Quality Control

Documentation

Education

Bachelor of Science in Analytical Chemistry

Tools

UPLC

HPLC

FTIR

UV/VIS

Karl Fischer

pH Meter

Osmometer

Density Meter

Particle Size Analyzer

Job description

About PCI

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.

Job Details

Position Title: QC Chemist I

Location: Bedford, New Hampshire

Department: Quality Control (QC)

Reporting To: Sr. Manager, QC & Analytical Development

Responsible For (Staff): No

Job Description

This position will have responsibility to support various activities in the Quality Control Laboratory. This includes testing the following sample types R&D, in-process, finished product, stability, as well as raw materials. Job duties may also include assisting in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management.

Essential Duties and 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
• Logging and tracking of samples and chemicals. Order chemicals and laboratory supplies as needed Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely and in 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 Performs routine data generation and problem solving Performs other duties as assigned.

Qualifications

Required: 0-3 years relevant Analytical Chemistry experience, preferably in Quality Control Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study General knowledge of analytical techniques using instruments such as: pH Meter, Osmometer, Density Meter, UPLC, HPLC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer. Excellent organizational skills and ability to document technical data Excellent interpersonal skills and the 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 Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment #LI-CW1

Join Us

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.