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.Summary of Objective:The primary function of this role is to perform basic tasks such as collect and process environmental samples from across all Rockford facilities using aseptic technique. In addition, this role is responsible for supporting basic microbiological functions and daily monitoring of the Laboratory temperature for various equipment in the Laboratory. This role may participate in training of other analysis in techniques for which competency has been demonstrated. There are no supervisory responsibilities associated with this role.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.GENERAL RESPONSIBILITIESReceipt and logging of 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 Generation and documentation of raw data in accordance with ALCOA principles Knowledge of ICH Guidelines which pertain to job function Knowledge of USP and EP general chapters which pertain to techniques within job function Training of other analysts in techniques for which expertise has been demonstrated Attendance at staff meeting/laboratory departmental communication huddles On time completion of assigned training in ComplianceWire Participate in internal Health and Safety audits including developing actions and follow up Retains product on completion of testing and raw data upon issuance of analytical report/certificate of analysis Maintains a high level of good housekeeping including ensuring that all dishes are cleaned in a timely manner once analysis is complete. Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence Ensure that all waste materials including biohazard/solvents are disposed of in a safe and timely manner. Implementation and execution of continuous improvement activities Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory Travel to another facility to perform environmental monitoring Attendance to work is an essential function of this position This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Performs other duties as assigned by Manager/Supervisor.SPECIFIC RESPONSIBILITIESPerform basic tasks:Daily Monitoring of Temperature of equipmentSampling of environmental samples (viable Air, compressed air, non-viable Air, Surface) from across all RFD facility, maintaining trending data for the facilityRegularly packs up equipment to be sterilized and puts away in an organized fashionSampling and analysis of water using aseptic technique, maintaining trending data for the facilityPrepare microbiological media, reagents, buffers, etc. using applicable Media Prep SOPs, procedures, and recipes.Perform Growth promotion and sterility of ready-prepared and in-house prepared Microbiological media, buffers, reagents and solutionsInventory/Monitor quantities of media, reagents, buffers, and raw materials.Orders inventory where needed by utilizing the Kanban system ordering sheetReceives new inventory and puts away in correct location in a timely mannerReceives and processes microbiological samples (such as water, Biological indicators)- incubation, examination, and documentationVerify balance and pH meter as per scheduleCleans daily interior of the biosafety cabinetRetains and files raw data for archivingParticipate in Product OOS investigations and assist in the determination of root cause On time investigations including raising extensions prior to the due date if required Participates in weekly cleaning of the microbiology laboratory Perform Equipment maintenance such as weekly cleaningSpecial 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
Stationary Position: Under a 1/4 of the day.
Move, Traverse: 3/4 of the day and up.
Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up.
Ascend/Descend or Work Atop: Up to 1/4 of the day.
Position self (to) or Move (about or to): 3/4 of the day and up.
Communicate or exchange information: From 1/2 to 3/4 of the day.
Detect, distinguish, or determine: 3/4 of the day and up.
On an average day, the individual can expect to move and/or transport up to 25 poundsbetween 1/4 and 1/2 of the day.This position may have the following special vision requirements.
Close Vision ☐ Distance Vision ☒ Color Vision ☐ Peripheral Vision ☐ Depth Perception
Ability to focus ☐ No Special Vision Requirements
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Fumes or airborne particles for 1/4 to 1/2 of the day.
Toxic or caustic chemicals for 1/4 to 1/2 of the day.
Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 3/4 of the day and up.
Work near moving mechanical parts for up to 1/4 of the day.
Exposure to micro-organisms for ½ the day and up.
The noise level in the work environment is typically, moderate.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.Required:
Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
College Level Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
High Standard of Report Writing
Preferred:
Ability to demonstrate attention to detail.
Ability to adapt to a changing work environment.
Ability to hold oneself in a professional manner.
Ability to identify and resolve problems in a timely manner.
Ability to exhibit sound and accurate judgement
Ability to demonstrate excellent time management skills
Ability to take ownership of issues and works towards resolution
#LI-DT1Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)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.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
