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.

DEPARTMENT NAME: Physicochemical Quality Control REPORTS TO: Physicochemical Quality Supervisor

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This position will have responsibility to support a wide variety and complex activities in the Quality Control Laboratory. This includes testing the following sample types, packaging material, in-process, finished product, stability, as well as raw materials. Job duties may also include performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management. Train others in complex analytical techniques.

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

· Ability to independently troubleshoot and solve assay and instrumentation issues

· 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

· Performs routine data generation and problem solving

· Collects and washes glassware and other supplies from QC labs

· Handles biohazardous or chemical waste as part of housekeeping responsibilities

· Perform laboratory maintenance such as Incubator, BSC, refrigerator, freezer sanitization, general labs cleaning and other duties as necessary

· Using good manufacturing documentation practices to ensure accuracy and compliance records

· Keep track of accurate inventory sheet and place order as necessary

· Replenishes the lab stock daily, insure proper rotation of dated inventory and maintains cleanliness of the QC labs

· 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+ years relevant Analytical Chemistry experience, preferably in Quality Control

EDUCATION –

· Vocational Education and Training (Junior colleges) of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study.

QUALITIES –

· 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

· Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves

· 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 management and staff within the QC labs

MANAGERIAL & SUPERVISORY RESPONSIBILITIES -

· Not Applicable

TRAVEL –

· Not Applicable

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.