Operations Specialist

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Job Title:    Operations Specialist
Summary of Objective:
The position audits production room documentation, checks equipment challenges, in-process inspections and ensures samples/AQL requirements are met. These associates are responsible for performing real time batch record and documentation review and or co-signs during batch processing to drive improvements into our Right First Time (RFT) metrics. They are also responsible for leading and realizing continuous quality and process improvements on the production floor by mentoring, coaching and training their operational counterparts
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. 

1.    Perform operational production room approvals after product and lot changes
2.    Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct
3.    Ensure products are packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications. If not, this individual will contact the appropriate personnel to recalibrate and/or remediate the issue.
4.    Review batch record (MPI’s) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately. Conduct periodic checks to confirm hourly inspections are being performed correctly and on track to meet AQL requirements
5.    Review sampling pages to ensure samples have been taken, labelled, and documented appropriately 
6.    Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely.
7.    Check to ensure portable equipment has been cleaned and documented correctly on quality form.
8.    Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment.
9.    Ensure recovery stations are segregated from product flow
10.    Confirm bulk material and components for job are correct and kept covered
11.    Review each equipment clean room logbooks for correct clean room, entries are complete, correct, and legible
12.    Review temperature and humidity data to ensure within acceptable job parameters
13.    Identify proactively gaps in batch records and TER's to mitigate deviations and documentation errors.   Participate on improvement teams (i.e. FMEA's, Kaizen, batch record etc.) as needed 
14.    Report quality event notifications for issues encountered on the production floor to OPS Mgmt
15.    Performs/supports end of shift BR review and supports/completes FORM-0001908 (QA 903
16.    This position may require overtime and/or weekend work. 
17.    Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
18.    Attendance to work is an essential function of this position
19.    Performs other duties as assigned by Manager/Supervisor.
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: 3/4 of the day and up.
-    Detect, distinguish, or determine: 3/4 of the day and up. 

On an average day, the individual can expect to move and/or transport choose an item
choose an item.
 
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.
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:
-    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. 
-    High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. 
-    2-4 years relevant experience in production, equipment and or process
-    Must demonstrate effective listening, coaching and interpersonal communication skills    

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.