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Batch Record Quality Specialist II


Rocky Mount, NC
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Job Details


The **BRQ Specialist II** is primarily responsible for the review of subassemblies utilized in the manufacture of finished product batches (Pharma/Device) for commercial distribution domestic and internationally. This position will be independent of the manufacturing review and must have an understanding of the implications of the work and knowledge of the context in which the work is being performed.

The **BRQ Specialist II** is responsible for conducting technical quality and compliance reviews in accordance with current Good Manufacturing Practices (CGMPs), FDA regulations and Standard Operating Procedures (SOPs).

The **BRQ Specialist II** makes sound decisions to ensure quality compliance and all procedural requirements are met for the approval/rejection of each subassembly. This individual performs a variety of job functions in the Batch Release department, which includes auditing of subassemblies, training, and completion of assigned projects.


**Quality Review Responsibilities includes but is not limited to the following:**

+ Reviews batch records for cGMP compliance, Good Documentation Practices and FDA regulatory requirements in order to approve/reject finished drug product for commercial distribution.

+ Reports on batch deficiencies as noted during review that may delay batch release and consults with supervision or management on decisions for all issues.

+ Plans for the completion of the batch documentation review in accordance within established schedules.

+ Assures that all documents received in the batch release area reviewed for completeness and accuracy.

**Additional Responsibilities:**

+ Ensures that batch records are archived in accordance with internal procedures and regulatory requirements.

+ Performs other related assignments and duties as required and assigned.

+ 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 **BRQ Specialist II** preferred Associate's degree, or four years of batch record documentation review. High School Diploma with six plus years of batch record review.

Preferred: The position requires a minimum of two years of related experience in an FDA regulated industry (preferably in in quality assurance or quality control) with knowledge to facilitate a quality batch record review. Must possess the basic knowledge of cGMPs and FDA requirements and be familiar with master formulas and batch records. Excellent organizational, interpersonal and communication skills (oral and written). Proven ability to work with minimum supervision. Must have the ability to work independently in prioritizing batch record review based on assessment of department needs.


The **BRQ Specialist II** position requires lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis. The incumbent may be required stand up for periods of up to 4 hours, use a computer for up to 8 hours and walk up and down stairs.


The **BRQ Specialist II** position may require some overtime and weekend work to meet the site goal release requirements each week. The incumbent 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.

**Other Job Details:**

+ **Last Date to Apply for Job: 3/8/2018** Additional Location Information: Rocky Mount, NCEligible 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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