Nov 17, 2018
Pfizer is committed to the delivery of safe and effective products to patients and consumers, a Fundamental element of our Company's Purpose and Mission. To meet this commitment, Pfizer maintains a quality-focused culture to ensure the highest priority is placed on the safety, efficacy and reliability of our products, the safety of our patients and consumers, and the quality of data supporting regulatory submissions and interactions with our stakeholders.
The supplier auditor position is responsible for performing cGMP audits and assessments of contract vendors, site suppliers and site service providers. The supplier auditor will assess programs, processes and procedures, to assure compliance with policies and that the performance and quality of services conforms to established standards and regulatory agency guidelines.
This position is responsible for performing self-inspections at the Kalamazoo site as assigned.
As assigned, independently conduct, participate and lead audits and assessments of contract vendors, select raw/packaging material suppliers and site service providers. Lead complex investigations into supplier related issues as assigned using Six Sigma tools.
Assess adherence of auditee to relevant cGMP and regulatory requirements including but not limited to:
+ Assess whether employees are properly trained for their responsibilities
+ Assess adequacy of facilities and equipment used for manufacturing and testing of materials and products
+ Assess compliance with cGMP and regulatory requirements, Quality Agreement requirements, and Pfizer expectations
+ Assess and report weaknesses that could lead to non-compliant manufacturing and / or distribution of products
+ Assess the operations executed at the supplier (e.g., production, packaging, testing, storage, distribution, supplier management) for their adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectations
+ Communicate relevant Quality, EHS and business information to the supplier in an effort to maintain and enhance the relationship between the audited entities and Pfizer
Lead the audit at the supplier. Responsibilities for this activity include but are not limited to:
+ Schedule the audit
+ Lead audit preparation activities
+ Perform the audit execution
+ Prepare the audit report within the specified time frame
+ Review auditee's audit response (s)
+ Perform audit follow-up activities as required
+ In appropriate situations, initiate reviews through consultation and agreement with others, including subject matter experts
+ Maintain the appropriate database with any relevant information pertaining to the supplier audit.
+ Maintain and expand current knowledge of applicable laws, regulations, guidelines, and other pertinent policies, procedures, and standards that could impact the operations at the supplier.
+ Can effectively cope with change during an audit
+ Can relate to and has the ability to communicate and interact with colleagues at all levels of the organization
+ B.S. in Chemistry, Biology, Microbiolgy and a minimum of 10 years of progressive, challenging experience in biopharmaceutical / device industry/sterile pharma required, to include Quality Control / Assurance, Manufacturing and cGMP auditing):
+ Experience in Quality auditing across a variety of product types and dosage forms (e.g., sterile and non-sterile pharmaceutical drug products, biologics, combination products and medical devices), materials (e.g., registered starting materials, APIs, excipients and packaging materials) and services (e.g., laboratories)
+ Is qualified in three or more of the following technical skills: sterile and non-sterile pharmaceutical drug products, biologics, combination products, medical devices, analytical and API.
+ Must be adept at managing multiple tasks and changing assignments based on changing priorities. Is willing to proactively propose tasks as needed
+ Good organization skills for audit preparation, audit conduct and audit tracking, as well issuance of audit reports aligned with site audit metric targets
+ Has the ability to recognize symptoms of problems or situations that require further evaluation, analyze symptoms to determine potential causes and suggest possible corrective actions. Can independently determine when input from subject matter experts is necessary in order to support these activities and actively seek out their support.
+ Ability to work independently
+ Recognized Auditor certification preferred
**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
Must be able to travel domestically frequently and internationally as required.
Ability to travel up to one-two weeks per month
**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.
**Last Date to Apply for Job:** 11/30/18
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.
Kalamazoo, MI, USA