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Laboratory Compliance Specialist

Employer
Pfizer
Location
Chapel Hill, North Carolina
Salary
Competitive
Closing date
May 23, 2021

View more

Sector
Pharmaceutical, Laboratory
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As a Laboratory Compliance Specialist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. With your deep knowledge in the discipline, you will be an active team member who influences at the project team level.

You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others to ensure a robust Compliance and Quality Culture. Your ability to plan will help in supporting project and method life cycle management deliverables. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to achievement of goals and influences at the work group/project team level.
  • Assist in the establishment of analytical procedures and interpret results/technical data.
  • Communicate progress, plans, requirements and risks to the senior analyst, manager, stakeholders in partner groups and higher management informally and, if required, formally through written reports and presentations.
  • Actively participate and report progress into cross-functional project teams to meet customer expectations, project milestones and Good Manufacturing Practices {also cGMP} standards.
  • Prepare and review technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls.
  • Develop analytical methodologies and strategies needed to progress biotherapeutic products in the pipeline.
  • Oversee change management strategy and execution for the Analytical R&D organization.
  • Interface with multiple ARD functions and strategic partners such as Quality Assurance, Regulatory,, and commercial supply.
  • Ensure that GMP changes are executed efficiently and effectively through managing the creation, evaluation, execution, and closure of GMP changes based on ARD's quality requirements, Pfizer Quality Standards, and defined processes.
  • Open dialogue with change owners, area managers, and key stakeholders is essential to consider the overall impact of changes.
  • This candidate is also accountable for enhancing the overall Quality culture and maintaining an audit and inspection ready state (in partnership with ARD management). This candidate will support the management of GMP instrument systems where needed to enable an agile fit-for-purpose program.
  • Excellent written and communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment are essential for the position.
  • Provide the necessary documentation for regulatory submissions as required and writes deficiency responses.


Role Responsibilities:

The qualified candidate is responsible for the following tasks across Pharm Sci ARD sites:

Facilitate Change Control Review Committee meetings:
  • Maintain routine schedule of meetings, ensure appropriate quorum is represented, and specific individuals are invited as needed [based on agenda]
  • Call for agenda items, publish agenda and publish meeting minutes and attendance in a timely manner and maintain a GMP records


Change Planning:
  • Ensure the appropriate change planning is taking place by engaging with the appropriate stakeholders
  • Ensure changes are grouped per regulatory/validation strategies

Assist with Quality System Oversight:
  • Assist with the creation of clear and concise parent change records to support GMP changes; this includes assisting and coordinating write-up of complex changes or as needed to support ARD.
  • Assist with the creation of change management action items (child records) needed to support a GMP change
  • Routinely query the change management system for schedule adherence/performance:
  • Act as designated ARD representative for the Biologics Change Review Committee
  • Ensure records and action items adhere to ARD procedural requirements

Metrics:
  • Develop metrics that are designed to communicate the overall health of ARD Quality systems, including the Change Management Quality System
  • Review and interpret metrics (key quality indicators), provide assistance and input to determine action plans needed to maintain or improve the state of compliance within ARD
  • Prepare and present metrics to site leadership team, or report to appropriate QA representative

Training:
  • Develop, maintain and provide system training to user groups and/or individual users, as needed.


Compliance:
  • Serve as an Subject Matter Expert (SME) for matters related to Change Control and general compliance and Quality culture within the laboratory.
  • Optimization and implementation of Pfizer Quality System (PQS) elements that impact or potentially impact ARD, including review and oversight.
  • Completion of CAS assessments associated with new or revised PQS
  • Optimization of SOPs, policies, and compliance standards associated with Quality and Compliance initiatives
  • Support audit and compliance strategy implementation efforts, including inspection readiness training, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.
  • Support data integrity efforts as needed, including detection of potential gaps and partnership with laboratory personnel for remediation efforts.


Other job duties as required by business needs.

Qualifications

BASIC QUALIFICATIONS
  • Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering or equivalent discipline.
  • Minimum five (5) years of experience in a pharmaceutical and/or medical device production environment.
  • Previous experience working with change management processes or process validation for a medical device and/or pharmaceutical company is required.
  • Familiarity with U.S. FDA 21 CFR Parts 210, 211, and 820, and/or ISO 13485
  • Quality and business process knowledge:
    • Understanding of how the change control process affects, and is affected by, other elements in the Quality Management System.
    • Ability to identify and recognize how the change control process potentially affects the wider business of the company
  • Leadership skills:
    • Demonstrated ability to communicate and interact with all levels of the organization including management
    • Strong interpersonal skills to provide training
  • Individual skills required:
    • Strong proofreading and technical writing skills, as well as exemplary attention to detail
    • Strong organizational and prioritization skills
    • Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
    • Demonstrated initiative and ability to work independently while handling multiple tasks
    • Strong computer knowledge (MS Office Suite)
    • Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
  • Excellent verbal and written communication skills
  • Fluent in English both speaking & writing


PREFERRED QUALIFICATIONS
  • Project management experience
  • Experience with preparation and/or facilitation of regulatory inspections (U.S. FDA, EMA, etc.) is preferable.
  • Strong knowledge and understanding of cGMP regulations


Other Desirable Attributes:

• Excellent documentation skills

• Quality Risk Management

• Experience with UV, HPLC, pH, Bioburden, Endotoxin, PCR, and other similar laboratory instrumentation and methodologies

• Self-motivated and highly effective in a team-based environment

• Effective oral and written communication skills

• Experience with laboratory data systems such as Laboratory Information Management Systems, TrackWise, ELN is helpful


    PHYSICAL/MENTAL REQUIREMENTS

    Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

    Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.

    Position requires occasional light lifting and periods of standing, sitting, or walking. May be required to work in environments of varying noise levels.

    While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts.

    Mental Requirements

    Ability to perform mathematical calculations and the ability to perform complex data analysis.

    Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

    Occasional work related travel may be required.

    Sunshine Act

    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Research and Development

    #LI-PFE

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