QC Chemist II

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.

The QC Chemist II 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. Ability to train others in analytical and wet chemistry techniques.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples.
• Ability to troubleshoot assay and instrumentation issues independently or with support
• Assist in deviation investigation, out-of-specification or aberrant results and process changes
• Author and/or review of GMP documentation including test methods, protocols, reports and raw data
• Independently perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals
• 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 requirement
• Work independently under general supervision and direction
• May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation
• Other duties, as assigned

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• 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

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 2-5 years relevant Analytical Chemistry experience, preferably in Quality Control and in a pharmaceutical company setting.
• Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study
• Working knowledge of analytical techniques using instruments such as: UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, Osmometer is required.
• General knowledge of cGMP, ICH, USP, and global compendia regulations and guidance's, particularly as related to analytical method validation and stability studies.
• Excellent organizational skills and ability to document and present 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.
• Ability to work with minimal supervision on scientific projects.
• Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
• Proficient in MS Office. Experience with lab based data management systems a plus.
• Scientific technical writing ability including authoring and revising SOPs or technical reports.
• Experience in troubleshooting of assay and equipment issues.

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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.