Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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: Performs routine and advanced calibration testing on laboratory and plant equipment to assure they are calibrated correctly and are providing accurate measurements.
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.
Perform routine calibration of various devices as assigned by calibration supervisor, or manager.
- Manage workload to achieve production schedules and ensure completion within timeframe.
- Ability to coordinate with external calibration vendors to service instruments and equipment
- Ability to communicate professionally with other departments to coordinate calibration activities that are scheduled.
- Maintain all documentation in an organized and controlled manner in compliance with GAMP and FDA.
- Produce and maintain the proper paperwork (data sheets, certificates, stickers, etc.) in an organized and controlled manner in compliance with Good Manufacturing Practices and Good Documentation Practices.
- Reporting OOS results when results fall out-with the expected ranges and performing instruments adjustments where applicable
- Keep an inventory of the calibration standards and consumable supplies that can affect the quality of calibration results.
- Data entry and database use in accordance with any internal SOPs and external regulatory requirement.
- Perform peer review of calibration activities when required.
- Advanced troubleshooting, analytical and problem solving skills.
- Supports on-boarding of new equipment and instruments.
- Experienced in utilizing and calibrating tools and test equipment
- Working knowledge and understanding of laboratory and production instrumentation and equipment.
- Ability to learn new technical disciplines and apply previous experiences to new tasks.
- Perform periodic reviews and updates of calibration Work Instructions.
- Be able to complete emergent and assigned tasks unsupervised.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Performs other duties as assigned by Manager/Supervisor.
- Attendance to work is an essential function of this position.
- This position may require overtime and/or weekend work.
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:
- Valid Driver’s License
- Associate's Degree in a related field and/or 3-5 years related experience and/or training.
- College Level 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
- 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.
- 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.
- 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.
- Ability to demonstrate attention to detail.
- Experience with Blue Mountain RAM
- Experience with a wide variety of calibration test equipment.
- Ability to work independently.
The hiring rate for this position is $24.58-$27.65 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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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.
