Hiring company: Pfizer
ROLE SUMMARY
This position supports the Pfizer Sanford, NC Quality Assurance department by performing Quality Assurance activities related to change control and validation associated with clinical and commercial products.
Colleagues in this role should be able to demonstrate the following:
Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards to be a key contributor.
Identify and implement new processes and programs for quality improvement.
Contribute to the interpretation of cGMPs for commercial and clinical product.
Decision impact awareness on future quality and compliance as well as impact on own work group, department, and site.
Independently able to resolve complex issues and represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
Good judgment and correct decision making based on Pfizer procedures, PQSs, technical experience; and industry guidance / regulatory regulations.
Collaborates and independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.
Anticipates issues and elevates them to appropriate management attention immediately.
Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
Ability to organize own work to meet project deadlines.
Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development.
Effective written and verbal communication and interpersonal skills.
Can generate and interpret metrics to support continuous improvement of the site.
Plan and execute highly complex projects.
Suggest improvements and conducts continuous improvement activities.
Interface with and represents Quality Assurance in cross-departmental/cross-site/cross-network meetings, manage working area and projects/changes to accomplish change activities/project deliverables and/or whole projects.
Responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.
ROLE RESPONSIBILITIES
Responsible to ensure change control and validation activities meet all site and regulatory requirements for facilities, equipment and processes.
Review and approval of site documentation including but not limited to, change controls, cleaning/process/equipment/laboratory validation, data records, SOPs, automation, engineering and maintenance document and technical reports associated with clinical and commercial processing and ensuring adherence to regulatory agency requirements, ICH Guidelines, Pfizer standards, policies and values in a timely manner.
Assess existing Quality Systems and suggest and implement improvements to improve compliance throughout the site.
Initiate, lead working groups and/or manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.
Is a site point of contact for validation and change control activities.
Anticipates issues and elevates them to appropriate management attention immediately.
Support regulatory audits as needed.
Provide guidance/coaching to less experienced colleagues.
BASIC QUALIFICATIONS
Bachelor’s Degree (B.S.) in Chemistry, Engineering, Biology, or relevant scientific field is required, or equivalent relevant experience.
5-10 years relevant work experience in a cGMP pharmaceutical manufacturing, testing or Quality Assurance environment.
PHYSICAL/MENTAL REQUIREMENTS
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage.
Other Job Details:
Last Date to Apply: August 25th, 2021
Eligible for Employee Referral Bonus
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.