Sr Quality Specialist II

Responsibilities:

Utilize root cause analysis tools to drive to root cause of GxP deviations.

Complete impact analysis and identify appropriate corrective actions to prevent recurrence.

Collaborates with SMEs from other departments while hosting SME team meetings to ensure a cross functional evaluation is completed.

Oversee the administration of the prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.

Perform activities for MQA (i.e. Packaging line clearances, manufacturing room clearances, inspection of third-party contractor lots.

Maintains documentation in accordance with internal procedures and regulatory requirements (i.e. GMP, SOPs, etc.)

Works closely with Logistics / Supply Management on scheduling/distribution needs to appropriately manage workload.

Preparation of Investigation and Change Control elements for Annual Product Review Reports (APRs).

Collaborates with other facility colleagues to assure alignment of cGMP documentation practices where appropriate.

Supports and maintains an environment that fosters communication and teamwork within QA and related departments.

Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.

Performs other related assignments and duties as required and assigned.

Requires a Bachelor's degree, preferably in a scientific discipline, with a minimum of 6 years of experience in a pharmaceutical or related industry or graduate degree (MS preferred) with two years of experience in a pharmaceutical or related industry .

Demonstrated sound understanding, well developed working knowledge and ability in primary discipline.

Requirements:

Investigation into any unexplained discrepancies must be evaluated in terms of cGMPs, FDA requirements, NDA commitments and impact on product quality, safety and efficacy. Incumbent must be able to drive deviations to determine true root cause and identify appropriate CAPAs to prevent recurrence.

Help Quality team to meet day-to-day assignments

Demonstrate excellent understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing processes.

Identifies and resolves in-depth issues through collaboration with others.

Partners with colleagues in identifying and resolving potential compliance concerns.

Interfaces with appropriate Warehousing, Planning, Pharmacy, Operations and Quality management to implement the procedural requirements as outlined and within internal operating procedures.

Identifies and proposes opportunities for continuous improvement to quality systems

Effectively performs root cause analyses and determines corresponding corrective measures.

Working knowledge of TrackWise and Veeva is a plus

cGMPs, FDA requirements and regulatory commitments govern the QA function of the Sr. Quality Specialist II

Demonstrated ability with using appropriate and effective, written and verbal communication skills.

Strong written and verbal communication skills.

Demonstrates capabilities in project management.

Oversees the corrective action process, including identification of the "root cause and implementing and monitoring corrective measures.

Fosters teamwork through the use of interpersonal skills