at PCI Pharma Services in Rockford, Illinois, United States
Job Description
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:
Overall responsibility for the PCI Services Complaints team responsible for consumer complaints and complaint-related Trend Investigations. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management and maintaining GMP compliance and system improvement. This position assists with improving quality system processes and the complaint process via risk assessment and process improvements. In addition, this role involves supervision of 5-8 individuals that write complaint responses, assist with Investigations, and participate in Improvement projects.
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.
+ Accountable for overall management, reviewing, planning, and administering of resource allocation and workload planning for the Quality Engineering staff reporting directly.
+ Responsible for direct supervision and personnel development including training and mentoring of direct reports.
+ Lead conference calls and customer meetings related to consumer complaints trends/etc.
+ Oversee and investigate consumer complaints and complete complaint responses expedited complaints (for confirmed or Field Alert Reports (FAR)/Recall) in a formal report.
+ Oversee and provide Technical writing, support, and review around complaint investigations, deviation investigations, etc.
+ Meet with management and supervisors to discuss likely root cause scenarios for critical investigations and complaints.
+ Oversee and write/revise SOP’s/WP’s and submit change control and assist with routing in the E-Doc system.
+ Assist with oversight and management of the Risk Management program as needed.
+ Responsible for the administration, implementation, and project management of assigned, special projects, including using standardized methodology. Analyze metrics for trends, identify root causes, and implement actions to mitigate negative trends.
+ Statistical assessment of data to drive improvements.
+ Analyze customer and business needs in the determination of Quality Engineering strategies.
+ Lead or participate in Quality system optimization teams (i.e. lean, streamline, efficiencies, etc).
+ Work closely with internal departments to partner on projects as needed. Participate as Quality Engineering representatives for Customer quarterly review meetings when required.
+ Oversee, organize, and present training on investigations, Root cause analysis, and CAPA. Participate in customer audits.
+ Participate in internal audits.
+ Participate in Regulatory audits.
+ Oversee and present quality-related metrics and key performance indicators for the team’s performance.
+ Oversees coordinating quality activities of the team to ensure that the goals and objectives of the team are accomplished.
+ This position may require overtime and/or weekend work.
+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
+ Attendance to work is an essential function of this position.
+ Performs other duties as assigned by the Manager.
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 of performing 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: ?From 1/2 to 3/4 of the day. ?
+ Move, Traverse: ?From 1/2 to 3/4 of the day. ?
+ Operate, activate, use, prepare, inspect, or place: ?From 1/2 to 3/4 of the day. ?
+ Install, place, adjust, apply, measure, use, or signal: ?From 1/2 to 3/4 of the day. ?
+ Ascend/Descend or Work Atop: ?Up to 1/4 of the day. ?
+ Position self (to) or Move (about or to): ?From 1/2 to 3/4 of the day. ?
+ Communicate or exchange information: ?From 1/4 to 1/2 of the day. ?
+ Detect, distinguish, or determine: ?From 1/4 to 1/2 of the day. ?
On an average day, the individual can expect to move and/or transport ?up to 25 pounds?
??less than 1/4 of the day. ?
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 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 essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
+ ??Work is primarily performed at a desk and/or in an office environment.? for ??3/4 of the day and up. ??
+ ??Work near moving mechanical parts? for ?up to 1/4 of the day. ?
+ The noise level in the work environment is typically, ?quiet. ?
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 essential functions.
Required:
+ Bachelor’s Degree in a related field and/or 5-10 years of related experience and/or training.
+ ??College Level Mathematical Skills?
+ ??Intermediate Computer Skills: Ability to perform more complex computer tasks and 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. ?
+ ??High Standard of Report Writing?
+ Statistical knowledge and applied experience.
Preferred
+ ?Ability to set and achieve challenging goals.?
+ ??Ability to demonstrate attention to detail. ?
+ ??Ability to exhibit sound and accurate judgment. ?
+ ??Ability to follow instructions and respond to management direction. ?
+ ??Ability to identify and resolve problems in a timely manner. ?
+ ??Ability to display excellent time management skills. ?
+ ??Ability to adapt to changing work environments. ?
+ ??Ability to work independently and/or as part of a team. ?
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational exc
