Why Patients Need You.
The MQ Auditor is the primary quality contact for production personnel. This role will monitor production processes for compliance to cGMP standards.
What You Will Achieve.
Auditors perform and document the testing and inspection results to support product disposition and decisions based on inspection outcomes. Performs multiple functions and makes decisions in support of production processes. Ensures quality of finished product through sampling, testing and evaluation of drug products, as well as accuracy and completeness of batch record and audit documentation.
How You Will Achieve It.
- Audit compliance of product and processes against governing documents.
- Obtain a representative number of samples for visual inspection, physical testing (where applicable), retains and stability studies.
- Inspect and verify critical product labeling information for accuracy to ANSI AQL Z.14 standards.
- Manage multiple priorities and effectively communicate priorities to interdepartmental partners.
- Perform calibration of tools used for inspection activities.
- Use critical thinking and problem-solving skills to identify and correct situations which would create delays and/or downtime of equipment.
- Perform review of environmental conditions for controlled areas.
- Act with ownership and make quality decisions.
- Obtain certification as a controlled drug agent (CDA).
- Identify and initiate deviation process in areas of expertise.
- Act as a subject matter expert during health authority inspections.
- Adhere to all safety and health practices and procedures.
Qualifications.
Must-Have
- High school diploma with a minimum of 1+ years of related experience in a regulated industry with knowledge to provide guidance on quality related topics.
- Knowledge of FDA regulations, specifically cGMPs.
- Computer skills (Microsoft Office, Excel)
- Excellent organizational, interpersonal and communication skills (oral and written).
- Proven ability to make decisions and work with minimum supervision.
- Decision making and problem-solving abilities.
Nice-to-Have.
- Previous QA or QC experience in a regulated industry
- Previous experience in a field that requires priority on detail management in a self-regulated work environment.
- Pharmaceutical or manufacturing, medical office, pharmacy, banking, or purchasing are preferred experiences.
- Knowledge of specialized processes that require attention to detail such as basic accounting, operation of equipment, basic computer operations or bookkeeping software.
- Previous experience in controlled records documentation.
Physical/Mental Requirements.
- May require lifting 35 lbs. or less, sitting, standing for periods of up to 90 minutes, walking, bending for extended periods of time, and performance of repetitive motions for up to 60 minutes.
- Must also be able to perform mathematical calculations and some data analysis.
Non-Standard Work Schedule, Travel, or Environment Requirements.
- The position is required to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards.
- 1st shift position.
Other Job Details.
No budget for relocation.
The salary for this position ranges from $20.21 to $33.68 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. 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 applies only to the United States - Kansas - Mcpherson location.
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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