Specialist QO
Specialist QO
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$ 66500 - 110900
1 Vacancy
Job Description
Use Your Power for Purpose
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 riskbased 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 Pfizers dedicated and highly effective quality assurance team. You will evaluate purchased raw materials intended for use in API and drug product manufacturing operations. You will qualify and manage suppliers of raw and packaging materials. 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 an associate your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
Provide Real Time Quality impact assessments and decisions on raw material issues with minimal guidance
Ability to handle situations with limited complexity
Accurately assess consequences of decisions
Seek guidance for potential Regulatory impacts
Immediately escalate issues with potential market or stability impact
Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.
Evaluates data and releases raw materials that conform to corporate customer and regulatory standards. Maintains associated test plans.
Leads/facilitates/participates/completes investigations within API QO team
Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations
Participate in low to moderate complexity QRM assessments that gain approval through Site and Area QO Management
Participate in low to moderate complexity projects
Independently assess a wide range of Change Control activities (Plant trials Protocol development SOP and batch record changes) to determine potential Quality and Operational GMP impacts with minimal guidance
Provide audit support during Regulatory/Customer audits
Seeks input on product filings to support inquiry responses
Effectively communicate low complexity technical issues to SQ Raw Material QO Management
Here Is What You Need (Minimum Requirements)
MustHave
Applicant must have a bachelors degree with 0 years of experience; OR
an associates degree with 4 years of experience; OR a high school
diploma (or equivalent) and 6 years of relevant experienceExperience at a manufacturing site with deviation and lot release support desired.
Bonus Points If You Have (Preferred Requirements)
Experience: Quality Assurance/Control in lot release deviations and floor/product support preferred along with advanced experience with SAP LIMS QTS gLIMS SMS and Batch Tracker.
Prior experience managing vendor relationships. Experience with the QTS SCAR module.
Specialist QO must have the ability to effectively communicate through written and oral means. Understand the quality systems and be able to drive consistency between the vendors and Pfizer. This person needs to understand the concepts incorporated in Quality Assurance in a GMP environment along with negotiation and problemsolving skills. Must be capable of multitasking job tasks through multiple customer and plant processes.
PHYSICAL/MENTAL REQUIREMENTS
Extended time sitting on desk
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Relocation support is not available
Work Location Assignment:Flexible
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 providers 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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
