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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 RESPONSIBILITIES

Receipt 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 that pertain to techniques within job function Training of other analysts in techniques for which expertise has been demonstrated.Attendance at staff meetings/laboratory departmental communication hurdles.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 promptly 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 RESPONSIBILITIES

Perform basic tasks:

Daily Monitoring of Temperature of equipment

Sampling of environmental samples (viable Air, compressed air, non-viable Air, Surface) from across all RFD facilities, maintaining trending data for the facility

Regularly packs up equipment to be sterilized and puts it away in an organized fashion

Sampling and analysis of water using an aseptic technique, maintaining trending data for the facility

Prepare 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 solutions

Inventory/Monitor quantities of media, reagents, buffers, and raw materials.

Orders inventory where needed by utilizing the Kanban system ordering sheet

Receives new inventory and puts it away in the correct location in a timely manner

Receives and processes microbiological samples (such as water and biological indicators)- incubation, examination, and documentation

Verify balance and pH meter as per schedule

Cleans daily interior of the biosafety cabinet

Retains and files raw data for archiving

Participate 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

Participate in weekly cleaning of the microbiology laboratory Perform Equipment maintenance such as weekly cleaning

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

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 pounds

between 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 PerceptionAbility 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 of related experience and/or training.College Level Mathematical SkillsBasic 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 judgmentAbility to demonstrate excellent time management skills          Ability to take ownership of issues and works toward resolution

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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, 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.