SDO_Operator 1

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Operator I

San Diego

Clinical

Production - Ops

Production Supervisor

Non-Exempt

Production Manager

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Summary of Objective:

The Operator I is responsible for producing finished packaged and/or labeled clinical product (including kits) for PCI’s clients as per the batch instructions and following the principles of current Good Manufacturing Practice (cGMP).

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.

Ability to produce finished packaged and/or labeled product to established specifications, while adhering to current Good Manufacturing Practices, Company’s Standard Operating Procedures at all times. Ability to follow good documentation practices on all documentation. Operate any packaging and/or labeling equipment (if applicable) in a safe and efficient manner, while meeting objective without work related injuries or adverse effects to health. Package according to clinical packaging requirements including control of labeling and active/placebo supplies for various types of clinical studies including blinded studies. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position 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: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/2 to 3/4 of the day.
• Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: From 1/2 to 3/4 of the day.
• Ascend/Descend or Work Atop: From 1/2 to 3/4 of the day.
• Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: From 1/2 to 3/4 of the day.

On an average day, the individual can expect to move and/or transport up to 25 pounds

less than 1/4 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.

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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:

• High School Diploma or GED and/or 1-3 months related experience and/or training.

• Basic Mathematical Skills
• None                          
• Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familar context.
• Basic Reasoning: Ability to apply common sense understanding to carry out uninvolved written or oral instructions. Ability to deal with problems that involve only a few concrete variables in standardize situations.

• Other Required Skills.

Preferred:

• Ability to effectively work with other operators.
• Previous pharmaceutical clinical packaging and/or labeling experience is desirable.
• Capable of maintaining the established schedule to meet production requirements.
• Good manual dexterity.
• Knowledge and understanding of cGMP required.
• Basic communication and mathematical skills (to perform simple calculations when required).
• Ability to multi-task effectively.                                          

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.