The MQ Auditor is the primary quality contact for production personnel. This role will monitor production processes for compliance to cGMP standards. 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.
- 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.
- High school diploma with a minimum of 1+ years of related experience in a regulated industry with the 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
- 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.
• May require lifting 35 lbs. or less, sitting, standing for periods of up to 90 minutes, walking, bending for extended periods of time, and performing 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
Weekend and overtime work is required to meet the 12-hour shift schedule. 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. Travel for this position is minimal.
· Last Date to Apply for Job: August 8, 2022
· Eligible for Employee Referral Bonus: Yes
· Schedule: Third Shift
***Pfizer now offering ***** sign-on bonus for successful hire through August 31st***
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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