Supervisor, Quality Control
PCI Pharma ServicesAbout the role
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.
Summary of Objective:
The QC Supervisor coordinates the activities of the Inspectors in the Warehouse Receiving and Shipping area. The Supervisor oversees execution of quality control inspection, including establishing:
1) Appropriate procedures for inspecting
2) Expectations of QC inspectors and implementing continuous improvement in the QC function in order to exceed customer expectations.
3) The Supervisor will directly oversee the Warehouse QC Inspectors in this fast-paced operations team.
Essential Duties and Responsibilities:
- Schedule and coordinate resources to ensure QC activities are completed in a timely manner.
- Provide hands-on training for staff
- Set expectations of performance and hold him/herself and team accountable for meeting the expectations.
- Ensure materials are inspected per schedule and required data is entered into ERP.
- Ensure all QC Inspectors’ SOP and OJT training is up to date.
- Ensures gowning and safety procedures are followed by IQA inspection personnel in production areas, per approved SOPs.
- May perform QC line clearances, QC inspection or release of incoming GMP materials according to appropriate material specifications
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules
- Collects Warehouse QC Inspection metrics and uses data to develop and implement performance improvement goals.
- Perform NMR investigations
- Ensure department and company goals are met
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:
- Stationary Position: From 1/4 to 1/2 of the day.
- Move, Traverse: From 1/4 to 1/2 of the day.
- Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
- Install, place, adjust, apply, measure, use, or signal: From 1/4 to 1/2 of the day.
- Ascend/Descend or Work Atop: From 1/4 to 1/2 of the day.
- Position self (to) or Move (about or to): Up to 1/4 of the day.
- 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 up to 25 pounds less than 1/4 of the day.
Work Environment:
- Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day.
- Work near moving mechanical parts for up to 1/4 of the day.
- Work in high, precarious places for up to 1/4 of the day.
- Extreme cold (non-weather) for up to 1/4 of the day.
- Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
- The noise level in the work environment is typically, moderate.
Qualifications:
Required:
- High School Diploma and/or 3-5 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.
- 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.
Preferred:
- Ability to display excellent time management skills.
- Ability to effectively present information to various people as the job requires.
- Ability to identify and resolve problems in a timely manner.
- Ability to demonstrate attention to detail.
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