Lead, Quality Operations

PCI Pharma Services


Date: 5 days ago
City: Rockford, IL
Contract type: Full time
PCI Pharma Services
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 DESCRIPTION:



Position Title: Lead, Quality Operations


Location: Rockford, IL – Logistics Parkway


Department: Quality


Shift: 1st


Reporting To: Supervisor, Quality Operations


Responsible For (Staff): no



Provides direction to other team members by ensuring they have signed the roster, completed the appropriate inspections; assigning team members to the appropriate lines / tasks; ensuring Auditors and Inspectors have the necessary knowledge to perform job functions; and assisting Auditors and Inspectors with questions or issues



ESSENTIAL DUTIES AND RESPONSIBILITIES:


  • Responsible to lead the Quality Operations auditing team (Quality Inspector/Auditor), ensuring team goals are on track.

  • Communicates important information such as quality and team performance issues to the Quality and Operations Supervisor and or Quality Operations Manager. Complete the End of Shift Notes and communicates any Quality issues/topics to the next shift.

  • Completes and or corrects necessary documentation such as batch record entries.

  • Performs scheduling activities for the shifts by staffing the lines; reassigning the team based on production demands; managing and or backfilling the Quality Inspector/Auditor role.

  • Supports the production floor by answering any questions related to Quality. Supports and assists the Quality Inspectors/Auditors in the day to day activities.

  • Assists Supervisors by completing or reviewing paperwork; attending or leading meetings when necessary; and training new employees on the liens, SOPs, and cGMP.

  • Assists in the hiring of agency employees by interacting with the temporary employment agency and Human Resources; submitting results to the appropriate individuals and departments (e.g., Training, Quality); and training agency employees.

  • This position may require overtime and/or weekend work.

  • Makes good sound judgement to resolve any quality matters.

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

  • Attendance to work is an essential function of this position.

  • Perform Quality Health Check assessments to identify if processes and day to day activities are performed according to procedures.

  • Performs other duties as assigned by Manager/Supervisor.

  • Initiates Product / Process Deviations. Distribute Quality Event Notifications.

  • Obtains documents from the EDMS.

  • Initiate Change Requests for Batch Records.



Special Demands:


  • Stationary Position: From 1/4 to 1/2 of the day.

  • Move, Traverse: 3/4 of the day and up.

  • Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.

  • Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up.

  • Ascend/Descend or Work Atop: 3/4 of the day and up.

  • 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.




On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day



QUALIFICATIONS:


Required:


  • Skills testing requirements met at approved grade level for position.

  • 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.

  • High School Diploma or GED and/or 3-5 years related experience or training.




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 excellent time management skills.

  • Ability to display a willingness to make decisions.




Equal Opportunity
Employer/Vet/Disabled



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

Let’s talk future




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.

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