QC Chemist I

PCI Pharma Services; Madison (WI); On-site; USD 45,000 - 70,000; Full time

Job summary

Join a forward-thinking company dedicated to bridging life-changing therapies with patients. This role in the Quality Control Laboratory involves performing analytical testing, supporting investigations, and ensuring compliance with GMP standards. As part of a dynamic team, you will engage in validating instruments and maintaining laboratory operations. Ideal candidates will possess a Bachelor’s degree in a relevant field and have a passion for quality assurance in the biopharma industry. Embrace the opportunity to make a significant impact in a collaborative environment focused on innovation and excellence.

Qualifications

• 0-3 years of relevant experience in Analytical Chemistry, preferably in Quality Control.
• Excellent organizational and documentation skills required.

Responsibilities

• Perform routine analytical testing of various sample types in Quality Control.
• Assist in deviation investigations and authoring GMP documentation.

Skills

Analytical Chemistry

Problem-Solving Skills

Attention to Detail

Interpersonal Skills

Education

Bachelor of Science in Analytical Chemistry

Bachelor of Science in Chemistry

Bachelor of Science in Pharmaceutical Sciences

Tools

UPLC

HPLC

GC

FTIR

UV/VIS

Karl Fisher

Particle Size Analyzer

Densitometer

Osmometer

Job description

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 SUMMARY

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

JOB DUTIES

• 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
• Perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals with support
• 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 LSNE, 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
• Other duties, as assigned

PROFESSIONAL SKILLS

• General knowledge of analytical techniques using instruments such as: UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer and Osmometer is preferred

EXPERIENCE

• 0-3 years relevant Analytical Chemistry experience, preferably in Quality Control

EDUCATION

• Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study

QUALITIES

• 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

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
• Ability to sit or stand for prolong periods of time
• Must be able to walk and drive between locations
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
• Must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly
• Must be able to occasionally lift and/or move up to 50 pounds
• Comfortable with working/handling of hazardous materials

COMMUNICATIONS & CONTACTS

Works closely with quality assurance and quality control staff in performing varied work procedures and activities. Interacts with Operations staff.

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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.