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. Essential Duties and Responsibilities: Receipt and logging of stability samples into LIMS including setting up new product/test and specifications Works in an efficient manner to a high level of accuracy with minimal personal error On-time removal of stability samples from chambers per master schedule Accurate completion of stability reconciliation Set down of samples on stability including review and generation of required documentation by defined procedures Generation of new stability protocols per customer requests and management of current stability protocols Coordination of all laboratory DEA products which includes, creating and issuing new log forms, maintaining the sign-in log, requesting clearance for new analysts, disposing of old DEA products per federal regulations, control of incoming DEA samples, training of analysts on proper handling of DEA product, and providing the annual inventory list to the DEA. Coordination of maintenance and repairs of each of the PCI Stability chambers including scheduling maintenance before the required timeframe and coordinating other internal required departments (Security, Facilities, and Calibrations). Response to stability chamber alarms (during working hours) and working with other internal departments to assist in troubleshooting equipment. Perform alarm testing at random intervals. Participation in stability chamber investigations, including generating all requested data from products stored in the chambers during the affected time frame and assessing potential product impact On-time sending of completed stability testing COAs to the associated customers. Archiving of data upon completion of the testing period Knowledge of ICH Guidelines Management of the entire laboratory waste program, which includes proper disposal and management of samples from the stability chambers after the study has been completed. Generating proper documentation associated with the waste disposal Coordination and communication with external laboratories for sending out stability samples which PCI does not test Assist with IQ/OQ/PQ and generation of protocols for new stability equipment Orders reagents, consumables, and reference materials required for analysis On-time expiration review of chemical reagents and reference standards utilized in the stability per defined frequency Assist in the retrieval and sending of raw stability data upon customer request Participate in weekly customer meetings on the status of stability testing and upcoming pulls Ensures samples that require shipment to approved subcontractors is performed in accordance with the procedure On-time completion of assigned training in ComplianceWire Coordination and participation of internal Health and Safety audits, including developing actions and follow-up Participation in internal, customer and regulatory audits Maintains a high level of good housekeeping including ensuring that all glassware and ancillary items are cleaned in accordance with defined work practices Maintains a high level of safety and highlights any potentially unsafe act immediately to all and works with relevant personnel to prevent further occurrence Generation and documentation of raw data in accordance with ALCOA principles This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor. Required: High School Diploma or GED and/or 1-3 months related experience and/or training. Basic Mathematical Skills Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: Associate Degree in Science Pharmaceutical or medical device manufacturing experience Ability to demonstrate attention to detail. Ability to adapt to a changing work environment. Ability to hold oneself professionally. Ability to follow instructions and respond to management direction. Ability to exhibit sound and accurate judgment Ability to demonstrate excellent time management skills #LI-SW1 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, Diversity, Equity, and Inclusion (DEI) 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.