Master Control Coordinator - Quality Systems

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 Quality Systems MasterControl Coordinator is responsible for maintaining the activities relating to Master Control System.

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.

• Responsible for processing of Standard Operating Procedures, Work Instructions, Job Aids and Forms through Electronic Document Management System Master Control.
• Responsible for generated reports in Electronic Document Management System Master Control.
• These reports would be daily, weekly, quarterly and monthly.
• Responsible for training new employees on Electronic Document Management System Master Control.
• Responsible for providing Status of Documents/Forms to owners.
• Responsible for aborting actions, forms and packets in Electronic Management System Master Control.
• Responsible for managing Smartsheet reporting.
• In-depth working knowledge of MasterControl Docs and FBS workflows and overall system to assist with troubleshooting.
• Assist with transfer of change controls and actions from legacy Quality Management System to MasterControl.
• Various ongoing MasterControl related projects to assist with system and metric related compliance
• 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.

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:

• Bachelor's Degree in a related field and/or 1-3 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 prgrams.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• 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 demonstrate attention to detail.

• Ability to work independently and/or part of a team.

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

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

The hiring rate for this position is $19.96-$22.46 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), flexible spending account, and 401(k).

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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.