Quality Assurance Specialist (QA for QC)
Pfizer
ROLE SUMMARY
This position provides Quality Assurance oversight for Quality Control (QC) Department. Provide QA (Quality Assurance) review and approval of Quality method validation/ QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. The role required to act independently supports process improvement and facilitates the implementation.
What You Will Achieve
In this role, you will:
- Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol, amongst others.
- Provide final QA review and approval on change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.
- May also review and approve documents such as contract investigations, Protocol investigation, and other Quality Events/Lab Events, Electronic build of QC LIMS BUIL or any electronic record when needed, and all associated to compendial changes.
- Capable to Make quality decisions in real time according to regulations and procedures.
- Ability to work collaboratively with internal partners to resolve technical issues.
- Willing to perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.
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
- Ability to be problem-solving and analytical skills.
- Experience in Quality Control Laboratory cGMP’s Laboratory environment
- Attention to detail and the ability to work independently.
- Proven ability to work in a team environment through conflict resolution and negotiation
Bonus Points If You Have (Preferred Requirements)
- Experience in Quality Control Lab
- Strong problem-solving skills
- Ability to work independently and as part of a team
- Excellent time management and multitasking abilities
PHYSICAL/MENTAL REQUIREMENTS
- Ability to work in a fast-paced, dynamic environment.
- 50% on the floor time (walking/Standing)
- Able to manage different priorities.
- Occasionally lift and or move objects up to 30 pounds.
- Stand/walk during the entire length of the shift.
- Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.
- If needed, a gowning could be required and the use of other PPE (Personal Protective Equipment) if any special support if needed in Quality Control.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Regular business hours or shift schedule, if needed.
- Be flexible when weekend support is required.
- Travel requirements are minimal and will be coordinated in advance.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $66,500.00 to $110,900.00. 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.
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 disabilityrecruitment@pfizer.com. 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.