Job Description

What will you do?

Provide essential finished Commercial and Clinical product disposition by performing all aspects of quality batch issuance, review, verification, disposition, and release activities across various products in the Pharmaceutical (required), Medical Devices and/or Biologics industry sectors. You will have advanced knowledge of the US and EU GMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies as well as have significant experience interacting with internal and external batch release stakeholders. You will assure that no product error has occurred or, if errors occurred, assure that they have been fully investigated to effectively enable the finished batch release (approve or reject) disposition. This includes a high level of functional and technical capabilities, acquired through experience, qualification training and/or experience to ensure that each batch of finished Commercial and Clinical product is produced, sampled, inspected, and tested to ensure that it meets appropriate specifications.

EDUCATION
How will you get here?

* Bachelors Degree in a Science related field or comparable. Masters Degree preferred.

Responsibilities:

* Adheres to the fundamentals of cGMP as stipulated in 21 CFR Part 4, 11, 210, 211, 600, 820, 1300 and EU Directive 2003/94/EC and other relevant regulations and good documentation practices with a focus on patient safety.
* Collaborates with Clients to fully comprehend their Batch review and release requirements and the regulatory obligations which their company must fulfill.
* Uses sound knowledge of the governing regulations, authorizations, products, and processes, coupled with the experience of manufacturing and packaging, and its business requirements to thoroughly verify all aspects of the batch safety, identity, strength, purity, and quality.
* Carries out a full qualitative and quantitative analysis of all inputs into the batch creation process to include the impact examination of components, manufacturing, packaging, labeling, inspection, and testing results to confirm compliance.
* Considers all factors that may directly or indirectly affect the quality of the batch in view, such as environmental monitoring, analytical results, calibration, validation, preventative maintenance records, and investigations (Deviations and Complaints) to include the impact of split-site or multiple-site processing as part of the final batch release criterion.
* Ensures that only batches of products that have met the prescribed in-process and finished product specifications and regulatory requirements are dispositioned to be certified and released to the market or clinical study site.
* Ensures that batches of products that have not met the prescribed in-process and finished product specifications and regulatory requirements are dispositioned to be quarantined or rejected (when applicable) to prohibit use or release.
* Interacts with Operations, Quality (QA), and internal functional units for resolution of batch release quality issues or potential quality issues.
* Proactively identifies clinical batch review concerns and uses considerable judgment in resolutions and anticipating issues.
* Promptly communicates and escalates (when appropriate) issues contributing to batch release non-compliance, Out-of-Specification (OOS), or potential failure to Quality Management. Recommends steps to resolution, when appropriate.
* Supports product launch activities as required, with the execution of product launch rapid response team.
* Prioritizes batch record data reviews and Client releases to achieve objectives and deliver compliant results within a short-term and a long-term operational focus with guidance from the Production Schedule, Client Services, and Quality Management.
* Maintains both internal and external customer service expectations with clear, concise communication and a sense of urgency.
* Communicates delays promptly to affected parties (Quality, Supply Chain, Customer Service, etc.).
* Ensures the above-mentioned provisions, to include the cumulative processing impact are analyzed, and are satisfied before the finished goods batch is certified to be placed on the market.
* Represents QA and provides support to internal team meetings, as needed.
* Initiates and updates SOPs, as required.
* Trains and mentors junior staff on interdepartmental processes and in activities critical to the success of departmental batch review and verification compliance.
* Reflects the level of batch review compliance innovation to develop new ideas, methods, techniques, and services.
* Employs metrics to track the performance of Batch Record/Release Operations and Compliance.
* Supports other business needs, as required.

Knowledge, Skills, Abilities:

* A minimum of Three (3) years of finished goods commercial batch record release experience strongly preferred.
* Five (5) years of working pharmaceutical or medical device experience in a GMP environment, preferably in Quality.
* Have strong knowledge of regulatory requirements including FDA, EU MHRA, ICH, USP, EU regulations for cGMP, and other regulatory intelligence sources.
* Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, etc.) and impact on product safety, identity, strength, purity, and quality preferred.
* Ability to identify and prevent quality and compliance issues.
* Strong problem solver that uses effective approaches for choosing a course of action or developing effective and sound solutions.
* Take action that is consistent with available facts, constraints, and probable consequences.
* Proven initiative and demonstrated accountability in a fast-paced environment with a high degree of flexibility.
* Must be detail-oriented to detect errors or deficiencies on batch records with the ability to use sound judgment in discerning if documentation accurately and completely reflects packaging operations.
* Ability to communicate openly and effectively written and verbal in an engaging manner with colleagues of various levels of experience and management.
* Experience with Quality Systems (change control, deviations, complaint management, documentation management).
* Proficient with computers, word processing, and spreadsheet software (Microsoft Office products).

Physical Requirements:

* This position requires standing, bending, reaching, walking and talking as well as exerting up to 20 pounds.