Quality Assurance Specialist

Pfizer Pte Ltd.; Rochester (MI); On-site; USD 69,000 - 114,000; Full time

Benefits offered by this job

Relocation assistance available

Comprehensive benefits package

401(k) with Pfizer Matching

Paid vacation, holidays and personal/m

Job summary

Pfizer in Rochester, MI is seeking a Quality Assurance Specialist to ensure quality of clinical and commercial drug batches, maintain audit readiness, and support change control and CAPA processes on a penicillin manufacturing site. The role requires a Bachelor's or Associate's degree with relevant experience, strong knowledge of cGMP, and excellent teamwork and communication skills.

The position is on-site with some on-site manufacturing support and occasional weekend work; relocation may be

Qualifications

• Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience.
• Experience in the pharmaceutical industry and Quality administered systems
• Sound knowledge of current Good Manufacturing Practices (part of GxP)
• Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
• Effective written and oral communication skills

Responsibilities

• Evaluate and review clinical and commercial drug batches to ensure quality.
• Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
• Identify and address deviations from manufacturing and packaging standards.
• Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
• Contribute to project tasks and milestones, organizing work to meet deadlines.
• Learn and apply basic team effectiveness skills within the immediate work team.
• Make decisions within limited options to resolve basic problems under supervisor's direction.
• Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
• Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems.
• Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.

Skills

GxP knowledge

Teamwork

Written & oral communication

Pharmaceutical industry experience

Quality systems

Education

Bachelor's degree or higher

Associate's degree + 4 years experience

High school diploma + 6 years experience

Tools

ERP system

Job description

Quality Assurance Specialist### Quality Assurance Specialist申请: United States - Michigan - Rochester: 全职: 今天发布: 4965719**Use Your Power for Purpose**Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes. **What You Will Achieve**In this role, you will:* Evaluate and review clinical and commercial drug batches to ensure quality.* Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.* Identify and address deviations from manufacturing and packaging standards.* Approve investigations and oversee change control activities to maintain compliance with configuration management policies.* Contribute to project tasks and milestones, organizing work to meet deadlines.* Learn and apply basic team effectiveness skills within the immediate work team.* Make decisions within limited options to resolve basic problems under supervisor's direction.* Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.* Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems.* Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments. **Here Is What You Need (Minimum Requirements)*** Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience* Experience in the pharmaceutical industry and Quality administered systems* Sound knowledge of current Good Manufacturing Practices (part of GxP)* Ability to work effectively in a team environment, both within one's own team and interdepartmental teams* Effective written and oral communication skills **Bonus Points If You Have (Preferred Requirements)*** Experience at a manufacturing site.* Managing and writing deviations* Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management* Strong problem-solving skills* Ability to work independently and as part of a team* Excellent time management and multitasking abilities* Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance**PHYSICAL/MENTAL REQUIREMENTS*** Expected to spend time between office and shop floor as needed to support manufacturing.* This is a penicillin manufacturing facility. Any candidates applying must NOT be allergic to penicillin. **NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**This is a first shift position (0700-1530). The selected candidate will be required to support manufacturing as needed and be on premise for occasional weekend shifts. Relocation support available Work Location Assignment: On PremiseThe annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% 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.Candidates must be authorized to be employed in the U.S. by any employer.U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.**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.Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.Quality Assurance and Control