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Quality Auditor (QA for QC/BQ)


Rocky Mount, NC
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Job Details

The **Quality Auditor ,** primary responsibilities include: meticulous evaluation of laboratory data results to ensure compliance to procedures and acceptance criteria, thorough investigation of anomaly events and release of the Certificate of Analysis (CofA) for both Finished Drug Products and Active Pharmaceutical Ingredients ( API) distributed domestically and internationally. The QA Auditor makes sound decisions to meet quality compliance of US FDA, EU, MHRA, JA and product requirements. The position requires making critical judgments and advising on observations during reviews of documents and discussions. This position acts like a resource and a go to person for other individuals from the Chemical and Biological Laboratories.

**Role Responsibilities:**

+ Executes oversight of internal laboratories to ensure compliance to domestic and international standards in an effective, timely, and efficient manner.

+ Verifies the accuracy of raw data and demonstrate a good degree of initiative to resolve problems, discuss and research actions to be taken before finalizing a resolution.

+ Evaluates testing for compliance to all applicable SOP's, specifications and regulatory requirements and generates the C of A for finished products and Active Pharmaceutical Ingredients (API).

+ This position also executes the release of the API within the quality system and ssupports effective, timely, and efficient oversight of the compliance of internal laboratories.

+ Conducts monthly audit of the Incoming Quality, Chemical Quality and Biological Quality Laboratories and ensures adherence to SOP's, policies and procedure associated with the laboratory functions and requirements of the US FDA, EU, MHRA and JA standards.

+ This position may acts as Supervisor representative during the absence of the Batch Disposition Supervisor (examples include but not limited to the approval of Change Controls, SOPs, Specifications and miscellaneous GMP Documentation) and perform special assessments as required.

+ Demonstrates the ability to work/contribute in a team-based environment as a lead and a participant with exceptional interpersonal skills and adept problem-solving skills.

+ Assist with internal, Corporate, third party and Federal/State audits, including FDA audits, as applicable.

+ Supports and maintains an environment that fosters the Pfizer Own It culture within Batch Disposition and other departments.


The **Quality Auditor** **,** must have a Bachelor's degree in a scientific discipline (preferred) or other related area with a minimum of 5 years' experience with a pharmaceutical GMP environment in one or more of the following disciplines: Quality Assurance, Compliance Auditing, Investigation, Research & Development, Biologics, Quality Control, or Validation cGMP Compliance; or 4 years of direct quality auditing experience with understanding of Analytical and/ or Biological testing, laboratory investigations (LIR) and stability. At a minimum 80% of experience expected in Quality Lab and/ or Auditing roles. Thorough knowledge and understanding of pharmaceutical regulations and guidelines, including but not limited to cGMPs, GLPs, ICH, USP, FDA and other applicable industry guidelines. Intermediate to advanced familiarity with laboratory equipment, such as HPLC, GC, titrator, AA, pipette, TOC, and pH meters. Etc. Demonstrated working knowledge and understanding of laboratory procedures, sample processing / analysis, and lab calculations (including handling units of measurement and conversions). Ability to verify accurate transcription and handling of raw data in final reports while auditing documentation for compliance to all applicable SOPs and regulatory requirements. Strong organizational, presentation, meeting facilitation and technical writing skills. Possess attention to detail and good communication skills as verbal and written feedback to lab staff is required when issues are discovered during document auditing. Widespread knowledge of manufacturing-facility components needed: this role will be involved in the monitoring of designated studies, facilities, equipment, personnel, methods, practices, records, reports, and other QS controls for conformance with government regulations of GLP standards. Display familiarity with the non-conformity and resolution process. Professional certifications desirable but not required (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, etc.). Strong computer proficiency skills in MS Office, Word, Excel, Project, QTS (QARs / Events), and Empower LIMS System or equivalent.

**Physical/Mental Requirements:**

The **Quality Auditor** , position requires lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis. The incumbent may stand up to 2 to 8 hours, sit 2 to 8 hours, use a computer for up to 8 hours and walk up and down stairs.

**Non-Standard Work Schedule:**

The **Quality Auditor** , position may require overtime and weekend work as needed to meet the site goal releases each week. He/she 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 to none.

**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.

**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.

+ **Eligible for Relocation Package**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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