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.

Job Summary:

Responsible for applying and maintaining quality standards for Company services and products. Maintains documentation and records. Conducts incoming, in-process as well as final inspections. Works closely with production and warehouse to ensure customer specifications are met and comply with internal operating standards.

Essential Duties & Responsibilities:

• Consistently applies company SOP's relative to production, warehouse, quality and pharmaceutical standards

• Supports the packaging rooms (line clearance, room open and closure, AQL inspections)

• Supports the label generation room (label inspections and associated documentation)

• Supports the warehouse (incoming receipts, inspections and releases of materials being received into the plant)

• Creates IMRS's for incoming drug products (incoming material release specification)

• Manages the status of materials through JD Edwards (ERP system)

• Guides, coaches and directs production and warehouse staff with respect to Quality issues and concerns using collaborative problem-solving skills

• Review and approve batch records (production tracker)

• Review receiving reports to enable release of materials (release tracker)

• Creates and revises SOPs to ensure agency regulations are being met

• Provides client responses related to quality issues

• Responsible for monitoring and adhering to GMP as well as Health and Safety Practices under the Occupational Health and Safety Act, raising concerns or issues to the Site QA Manager

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules and standards

• This position may require occasional overtime and/or weekend wor

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Supervisor

Special Demands:

- Stationary Position: 1/2 of the day.

- Move, Traverse: 1/2 of the day.

- 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: None.

- 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.

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 following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• 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 (fork lifts) for 3/4 of the day and up.

• Extreme cold (non-weather) for 1/4 to 1/2 of the day.

The noise level in the work environment is typically, moderate.

Qualifications:

Required:

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.

• Basic Mathematical Skills

• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various 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.

Preferred:

• Ability to effectively present information to various people as the job requires.

• Ability to identify and resolve problems in a timely manner.

• Ability to display a willingness to make decisions.

• Ability to exhibit sound and informed judgment.

Join us and be part of building the bridge between life changing therapies and patients.

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.