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Batch Record Quality Specialist


Rocky Mount, NC
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Job Details

The **Batch Record Quality (BRQ) Specialist,** Batch Disposition is primarily responsible for the review and/or final release of finished package product (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,** Batch Disposition is responsible for conducting technical quality and compliance reviews and/or final release in accordance with current Good Manufacturing Practices (CGMPs), FDA regulations and Standard Operating Procedures (SOPs).

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

**Role Responsibilities:**

**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.

+ Ensures all documents are present as issued by the Index Sheet.

+ Ensures all blanks contain appropriate data.

+ Verifies all accountability calculations.

+ Verifies all Commodities, Active Pharmaceutical Ingredient (API), materials, and packaging components materials used are accurate and correct against on the Bill of Materials

+ Verifies the solution hold times were met.

+ Ensures that the temperature requirements and processing specifications are met throughout the manufacture/packing of the batch

+ Reviews Line personnel records for correctness and accuracy.

+ Verifies all Line clearances are properly documented.

+ Verifies all quality control sampling and inspection has been met.

+ Reviews all line interventions (aseptic).

+ Ensures applicable Government Contracts have been met.

+ Verifies all associated batch tickets and charts are present and accurate.

+ 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.

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

+ Verifies all applicable subassemblies have been approved.

+ Verifies all part of the batch record are present and have been audited.

+ Verifies the Water for Injection is approved.

+ Verifies any product restriction(s) have been resolved and are approved and removed.

+ Verifies all deviations are thoroughly documented and approved and product has been correctly dispositioned.

+ Completes applicable information on the Certificate of Analysis (CofA).

+ Plans for the completion of the batch release in accordance within established schedules and performs the timely disposition of product lots release in the HK System.

+ Ensures that all documents received in the batch release area reviewed for completeness, and dispositioned based on the review of the batch record data and lastly ensures the dispositioned batch record is archived in accordance with internal procedures and regulatory requirements (i.e. GMP, etc.).

**Additional Responsibilities:**

+ Assist with the closure of MDO packages and ensures the 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,** Bachelor's degree in a scientific discipline or other related discipline with a minimum of two years of experience reviewing product-related documentation and processes (batch records and batch-related records) preferred. Associated degree, with four years of batch record documentation review. High School Diploma with six plus years of batch record review.

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 is preferred. 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/release based on assessment of department needs.

**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:**

+ 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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