Pfizer Quality Investigations Approver in McPherson, Kansas
Responsible for reviewing and approving quality investigations and associated documentation. Assures that quality documentation meets cGMP and regulatory requirements to assure safety, identity, strength and quality of the product and associated processes. This position directly impacts the disposition of product and assures that the product meets cGMP and regulatory requirements to assure safety, identity, strength and quality. This position also strongly influences the overall regulatory compliance of the site.
Review and approve investigation documentation. Provide guidance identifying potential product impact and determine final product disposition through Exception Report/Quality Assurance Report approval.
Provides guidance on remediation and developing corrective and preventive action (CAPA) plans. Lead the successful closure of CAPAs through collaboration with peers in operations and other departments.
Function as a quality representative as needed supporting the reduction of incident initiation and continuous improvement of the system of quality investigations.
Provide Investigations training as required in conjunction with other plant Quality colleagues.
Provide real-time guidance on incident classification and proper actions to mitigate and limit potential product impact.
Requires Bachelor's Degree in Scientific/Technical field (i.e.Chemistry, Biology, Quality or Engineering).
A minimum of 3 years professional experience in Quality or Operations, primarily in a cGMP facility, or equivalent is needed to meet the objectives of this position.
Requires thorough knowledge of cGMPs.
Effective communication skills are required, both written and verbal.
Effective project management skills and demonstrated ability to manage multiple competing priorities.
Knowledge of the cGMP regulations is needed to assure compliance with regards to manufacturing and quality laboratory investigations.
Problem solving skills are required to provide an assessment of product impact in situations that are not procedurally managed.
Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access and Paradox).
Experience working in a cross-functional, matrix environment. ASQ Certified Quality Engineer and Six Sigma Green Belt preferred.
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.
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.
Other Job Details:
Last Date to Apply for Job: September 26, 2018
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.