15 days old

Sr. QO Specialist

Rochester, MI 48307
Apply Now
Apply on the Company Site
**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.


The Sr. QO Specialist is accountable for the development and oversite of the site investigation program, ensuring the adequacy of all site incidents (events, deviations, laboratory and human factor investigations) through coordinating, planning, assessing and reporting investigation effectiveness.This role is also accountable for investigator/approver training, SMART CAPA, program improvement reinforcement and effectiveness of the use of investigation tools available. In addition to the investigation program oversite this position will also be responsible for providing back up quality assurance support to manufacturing/packaging operations for medical device combo products. Support inclusive of (but not limited to) providing real time partnership engagement with operations, maintenance and quality teams and performing GMP document review/approval and batch/material release activities.


+ Own and ensure a robust investigation process for the site, through the consistent and effective use of investigation system SOP/s and tools, and strong investigation culture across the site.

+ Embrace the "one best way" philosophy by actively performing routine assessments and analysis of the site investigation system seeking out trends and developing opportunities to address the trends identified.

+ Work with site leadership and partner with center colleagues to develop a robust site strategy and action plans for improving the Investigation system, as areas of opportunity are identified.

+ Implement the Global Investigations Training Curricula for QO and EHS investigations; ensure ongoing support, active coaching, and the use of the structured on-the-job documents for qualification of new originators/investigators/approvers and for those that may need additional knowledge and skills. Work with Center resources as necessary.

+ Ensure sufficient training and coaching resources are available and occur in a timely manner to meet site investigation goals.

+ Accountable for PHP Lead activities and site investigation training lead, to ensure that all investigations training, tools and methodology are consistently used, including DMAIC methodology (M1/M2/M3) to ensure adequate RC analysis and CAPA, and PHP to reduce and prevent Human Factors.

+ Participate regularly and contribute to global discussion groups (ASK-MINE, SIL Discussion Group, others) sharing information between the groups and the site colleagues, replicating practices, and promoting/enabling site colleague participation.

+ Work closely with QTS MIR/LIR User Council Representatives to identify opportunities for system improvements, review proposed updates, and communicate planned changes to site QTS users.

+ Provide Quality oversight to Operations as needed.

+ Supports Incoming material inspection and release as needed.

+ Perform batch release activities such as batch record review as needed.

+ Independently writes and/or reviews SOPs, technical reports, project plans, etc.

+ Demonstrates complete knowledge of quality and manufacturing operations including both technical and compliance aspects.

+ Demonstrates understanding of current aseptic manufacturing best practices.

+ May also present/defend QA Quality Systems during audits/inspections.


+ BA/BS, or MS in Life Science (e.g. Biology, Chemistry etc.) with a minimum of 5 years of related experience in Quality Operations and/or Investigation execution.

+ Experience in a cGMP environment required.

+ Green Belt Certified.


+ Demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.


**Communication:** Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies. Strong interpersonal and influential skills.

**Reasoning Ability:** Strong analytical and problem-solving abilities. Decision-making based on a risk science-based approach.

**Technical:** Comprehensive understanding of cGMP guidelines outlined in CFR. Knowledge and demonstrated ability to apply Pfizer Quality Standards to ensure local practices and procedures reflect these requirements.Basic understanding of aseptic manufacturing highly desirable.


This is a penicillin manufacturing facility. All candidates applying mist NOT be allergic to penicillin.


Occasional work outside of standard day shift hours required based on need.

**Other Job Details:**

+ **Last Date to Apply for Job: June 15, 2021**

+ Eligible for Relocation Package: Yes


**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.

Quality Assurance and Control
Posted: 2021-06-01 Expires: 2021-07-02
Sponsored by:
ADP Logo

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Sr. QO Specialist

Rochester, MI 48307

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast