Location: Buena, NJ
The Quality Assurance Specialist II is responsible for writing, revising, reviewing procedures, protocols, and Quality Systems Validation reports, and investigations; documentation support as an individual contributor and through collaboration with laboratory and operation subject matter experts (SMEs), and continuous improvement activities. Additionally, they will be responsible for organizing and prioritizing workload in coordination with the Quality Assurance Manager to ensure all timelines and compliance requirements are met.
This position will review investigations to ensure quality assurance and regulatory compliance throughout the investigation, deviation, and CAPA Management process while adhering to applicable regulatory statute and standards. Supports the organizational unit by providing necessary data, writing reports, and conducting research on various topics. Stays updated on best practices and quality trends and regulatory requirements.
Reporting Relationships: No Direct Reports
- Writes clear, concise and thorough investigations for quality events using quality risk management principles. Edits work for spelling and grammar. Proactively identifies possible quality events and initiate steps to prevent identified events.
- Drafts and reviews Quality documents (i.e. validation protocols, risk assessments, and reports). Reviews laboratory and operation deviations and investigations.
- Performs Root Cause Analysis (RCA) using industry standards, such as FMEA, 5Whys, Fishbone diagram.
- Performs risk assessments to assess impact to product quality safety and efficacy.
- Manages CAPA and its effectiveness processes. Works with cross functional groups to verify CAPA implementation, effectiveness and timeliness. Identifies CAPA to remediate and reduce risks. Track and trend quality events and CAPA metrics.
- Identifies opportunities for continuous improvement.
- Acts as a QA liaison in internal project meetings.
- Assists with development/writing of quality SOPs, documents and/or reports as needed.
- Provides support during regulatory inspections and client audits, if necessary.
- Presents numerical data effectively; able to read and interpret written information.
- Recognizes the need for urgency in the responsibilities and makes attempts to meet all requirements and deadlines.
- Takes initiative to identify and correct any areas of risks/gaps in the current quality systems.
- Is reliable with respect to accuracy and completeness of work assignments.
- Is reliable with respect to attendance schedule, on-time arrival and diligent/productive work ethic throughout the day.
- Excellent organizational and planning skills with high attention to detail.
- Strong written, verbal, and interpersonal communication skills.
- Demonstrated strong analytical skills, and the ability to work independently against competing deadlines.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
- Performs other duties as assigned.
- Bachelor’s degree with 2-5 years of experience.
- Experience in the pharmaceutical industry preferably QA/QC.
- Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide process improvements. Of importance understands quality systems and QA support of manufacturing.
- SAP and LIMS experience preferred.
- Trending experience preferred.
- Possesses some knowledge of project management tools and has some experience supporting cross functional teams.
- Solid demonstrated ability to work on multiple projects and meet timelines.
- Communication: speaks clearly and persuasively; listens and gets clarification; responds well to questions.
- Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
- Demonstrates group presentation skills; participates in meetings.
- Physical Demands
- Ability to lift
- Inside and outside work
- Move between buildings
- Temperature variations
- Sit and stand for long periods
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.