Quality Receiving inspector I

PCI Pharma Services•San Diego, CA

20d

About The Position

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. Perform and document quality inspection activities of products at various stages of clinical production. Responsible for ensuring quality standards are maintained during all phases of clinical production. This position will focus on the QC inspection of packaging and labeling operations, and incoming materials inspection activities. In addition, the person may assist with document control activities and product lot disposition. 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. Selects products for tests and specified stages in production. Perform QC line clearance verification, in-process checks and monitoring of labeling and packaging activities. Ensures work is consistent between work orders to maintain clinical blinding requirements. Works effectively in a clinical packaging environment that utilizes serialized kit numbers. May perform QC inspection of incoming GMP materials according to appropriate material specifications Completes documentation of paperwork to ensure accuracy and correctness. Assist product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures. Interprets formulas to arrive as specified quality and reliability standards. May participate on Customer Project/Improvement teams. Records test data, using statistical quality control procedures. Supports accurate storage of retain components and/or finished goods. 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: 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: Up to 1/4 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): 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. undefined undefined undefined undefined undefined undefined undefined 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. Ø 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. Ø Work near moving mechanical parts for 1/2 to 3/4 of the day. The noise level in the work environment is typically moderate.

Requirements

High School Diploma or GED and/or 1-3 years 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.

Nice To Haves

Ability to adapt to changing work environments.
Experience in a CGMP environment
Experience with clinical study labeling and packaging.

Responsibilities

Selects products for tests and specified stages in production.
Perform QC line clearance verification, in-process checks and monitoring of labeling and packaging activities.
Ensures work is consistent between work orders to maintain clinical blinding requirements.
Works effectively in a clinical packaging environment that utilizes serialized kit numbers.
May perform QC inspection of incoming GMP materials according to appropriate material specifications
Completes documentation of paperwork to ensure accuracy and correctness.
Assist product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures.
Interprets formulas to arrive as specified quality and reliability standards.
May participate on Customer Project/Improvement teams.
Records test data, using statistical quality control procedures.
Supports accurate storage of retain components and/or finished goods.
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