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    Manager, Quality Operations - Rockford, United States - PCI Pharma Services

    PCI Pharma Services
    PCI Pharma Services Rockford, United States

    2 weeks ago

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    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.


    2nd shift:

    Summary of Objectives:


    Responsible for managing 2nd and 3rd shift daily operations of the IQA Receiving and Quality Operations Departments through the activities of the Supervisors, Leads, Auditors, and Inspectors.

    Responsible for the quality issues/events that occur on 2nd and 3rd shifts.

    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.

    • Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals, and customer demands.
    • Provide 24-hour support for Quality related issues either by phone or email.
    • Be observant of processes, performance, and behaviors, focusing on continuous improvement.
    • Manage budgets and plans for business growth.
    • Compile, analyze, and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Missed events, and Right First-Time metrics).
    • Provide support via emails, phone, Quarterly Business reviews/meetings, tours, audits, and investigations.
    • Facilitate Annual Product Reviews. Deliver customer satisfaction.
    • Perform and participate in tours of functional areas for internal, customer, and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues.
    • Provide training and presentations to all associates as needed.
    • Ensure headcount, staff, and production demands are met.
    • Ensure Quality issues are resolved appropriately and report results to Quality and Production Management.
    • Responsible for developing, reviewing, and approving department Change Controls for Standard Operating Procedures, Job Aids, Batch Records, Material Specifications, and Forms
      _._
    • Responsible for facilitating troubleshooting issues for the department's testing equipment and or working with vendors to resolve errors.
    • Collaborate with Project Management for New Product Development; ensuring batch record documentation and product launches are successful.
    • Oversee incoming, in-process, and finished goods inspections of products to ensure conformance to established standards.
    • Investigate root causes of quality events/defects and recommend solutions.
    • Oversee functions of Incoming Quality Inspection and Quality Operations.
    • Manage non-conforming products, materials, and reports (NMRs, Product HOLDs, Line Clearance Failures).
    • Manage Batch Record Right First-Time program.
    • Ensure compliance for onboarding and training new Quality team members.
    • Ability to partner and collaborate with functional departments.
    • Order and or approve supply requisitions.
    • Oversee Pest Control Program.
    • Oversee Mean Kinetic Temperature and Environmental Monitoring.
    • Primary Quality Contact for Business Units regarding operational issues.
    • Oversee retention of PCI, customer retain samples (retain cage), and outbound retain shipments.
    • Provide hands-on training ensuring employees are trained in quality functions.
    • Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.
    • Lead and drive improvement/harmonization initiatives across multiple facilities.
    • Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals, and objectives are on track for completion.
    • Report and escalate to Senior Management of any potential risks that impact Quality.
    • 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 Manager

    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 1-5 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

    Preferred:

    • Ability to effectively present information to various people as the job requires.
    • Ability to display a willingness to make decisions.
    • Ability to display excellent time management skills.
    • Ability to work independently and/or as part of a team.
    _\#LI-SW1_
    ​
    Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (om/)


    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 excellence and providing the industry leading customer experience.

    Our people make all of this happen, so providing an industry leading experience for our people is equally as important.

    By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers.

    We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program.

    We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

    PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
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