Description
**Why Patients Need You**
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
**What You Will Achieve**
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As a Specialist, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
**How You Will Achieve It**
+ Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
+ Suggest improvements and conduct continuous improvement activities.
+ Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
+ Review/Approve Deviations, CAPAs, and Change Controls related to facility, utilities, automation, and warehouse (WHSE). Escalate issues in a timely manner, and monitor open quality system records to closure.
+ Review/Approve Facilities, Utilities, Automation, Warehouse records to ensure compliance with approved directives/specification, site procedures and cGMP expectations
+ Review/Approve quality system documents such as SOPs, Work Orders, others as needed
+ Provide Quality oversight of facility related programs including calibration and maintenance, facility/utility monitoring, pest control.
+ Provide select Quality oversight of WHSE activities (shipping, receiving, materials storage and issuance)
+ Provide MQA (Manufacturing Quality Assurance) support as needed (area walk-throughs, other as assigned)
+ Provide close cross communication and collaboration with Customers and site MQA on site activities (e.g., warehouse activities, pest control and facility maintenance shutdown)
+ Assist with reporting and/or presentation of department metrics
+ Participate in audits: internal, external (vendor, partner), and regulatory inspections
+ Other duties as requested
**Qualifications**
**Must-Have**
+ Applicant must have a High SchoolDiploma (or Equivalent) and 8 years of relevant experience.
+ Associatesdegreewith 6 years of experience.
+ Bachelors with at least 3 years of experience.
+ Masters with more than 1 year of experience.
+ Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
+ Experience with clinical and commercial operations, pharmaceutical/biotechnology manufacturing, maintenance/calibration, and automation systems knowledge.
+ Proactive approach and strong critical thinking skills.
+ Detail oriented team player with effective planning, organization, and execution skills.
+ Excellent communication skills with internal and external personnel essential.
+ Ability to work effectively at a fast pace with cross site/functional departments.
+ Innovative, proactive, and resourceful: committed to continuous improvement
+ Experience with quality management systems (QMS), electronic documentation management systems (EDMS), ERP and maintenance systems (i.e., CMMS).
+ Experience supporting audits and regulatory inspections.
+ Must be able to work in a team environment within own team and interdepartmental teams.
+ Excellent communication and interpersonal skills.
+ Good working knowledge of Microsoft Excel and Word.
+ Ability to lift up to 25 pounds.
**Nice-to-Have**
+ Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener.
+ Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality.
+ Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure.
**PHYSICAL/MENTAL REQUIREMENTS**
+ Ability to lift up to 25 pounds
Relocation support available
The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
**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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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