Qa Product Release Coordinator Jobs

Experience working within project management practices described in the PMI Project Management Body of Knowledge (PMBOK.)

Education and/or Experience: B.A. in Business Management, Information Technology or similar relevant field;

Experience with change control and risk management.

Excellent MS skills including Excel, Visio, PowerPoint and MS Project, or similar project management software tools.

Experience using software project management tools, incident management tools and test management tools such as JIRA/Zephyr, Confluence are highly preferred.

Perform tasks after hours or on weekends as needed and as required by management/supervisory staff.

Communication skills: Possess the ability to convey updates, changes, and benefits of each release effectively.

Project management: Demonstrate expertise in coordinating schedules, tasks, and team members for on-time deliveries.

Stakeholder management: Collaborate with various internal teams, ensuring alignment and smooth execution of releases.

Analytical skills: Analyze feedback and data to continually refine release strategies and enhance the product.

External release demos: Host regular release office hours on platforms like Discord/YouTube, showcasing and discussing new features and updates.

Feedback analysis & synthesis: Analyze user feedback post-release to guide future product developments and release strategies.

Minimum of 10 years of experience in Quality Assurance and Release Management, with at least 5 years in a leadership role.

Develop and manage the release management process, ensuring that all releases are planned, tracked, and executed efficiently.

Deep understanding of quality assurance practices and a strong background in release management and release cycles.

Strong knowledge of SAP cloud offerings.

All internal transfers must have manager’s approval.

Manage high volume and high risk/complex projects, ensuring that they are delivered on time and within budget.

Quality assurance or document/ records management experience (must be clear on resume)

Archival of batch documentation in an electronic document management system.

Cultivates own working knowledge of QA & the roles within a cGMP environment.

Performs other administrative support responsibilities as requested.

Responsible for documentation support for QA Department staff

Tracks status and timelines of QA record review/approval and QA lot disposition.

• Previous project coordination experience

• Excellent customer service skills

• Computer knowledge and interest

• Assists in coordinating schedules

• Coordinates deadlines on all deliverables

• Assists in monitoring teams progress

Demonstrated knowledge of computers and knowledge of data management processes

Present feedback to management regarding areas that need improvement.

Submit weekly QA reports in a timely manner to Quality Assurance Manager/Supervisor.

Associates degree in Human Services, education, psychology, sociology or related field required. Bachelor’s degree preferred.

Minimum two plus years related experience

Demonstrated knowledge of quality assurance procedures and federal, state and local coalition laws and mandates

Excellent organizational and time management skills.

Sets annual budget/spending and manages expenses within department. Communicates staffing expectations to QA management.

Participates in 3rd party audits as assigned by management.

Delivering Results, Quality Orientation/BPE, Knowledge of Regulatory Requirements/Compliance - influencing.

Project/Program Management – leading ,demonstrating, and influencing

Management of direct reports for adherence to company policies, resolution of conflict and annual personnel performance measurement.

Support activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.

Escalate critical issues to senior management.

Must have extensive experience in a Quality Assurance role supporting root cause investigations / CAPA development.

Proven ability to manage projects of significant scope and complexity, while meeting deliverable timelines.

Excellent technical writing, presentation, and communication skills.

Broad GxP Knowledge and understanding across lifecycle of the product

Deliver presentations that persuasively communicate findings and recommendations to the management team and key stakeholders.

Monitor user experience metrics and provide local insights and advice to HQ teams.

At least two years of experience in user experience/operation/PM/quality assurance or related fields in the online e-commerce industry.

Strong written and verbal technical communication skills

Conduct local user research to explore local user behavior and preference.

Work collaboratively with other teams to solve users pain points.

Preferred Qualifications – Education and Experience

Responsible for personal daily task management, training plans and performance management.

Assists with data preparation for Quality Management Reviews.

Bachelors degree in scientific discipline or equivalent experience.

2 years QMS experience working in a regulated, GMP environment

2 years experience in IVD, including ISO 13485:2016 and MDSAP.

Collaborate with Intel global partners while learning about quality management systems and lifecycle management.

6 months of experience with Microsoft Office tools (Excel, PowerPoint, Word) or similar.

Salary range dependent on a number of factors including location and experience

Make recommendations for process and tool optimization based on data analysis is also a key deliverable.

Works independently with minimal guidance.

The candidate must be pursuing a Bachelor's degree in Engineering or Science (Electrical, Computer/Data, Mechanical, Materials Science, Chemical, or similar).

Excellent organizational and time management skills

L Typing and data entry skills

Must have good knowledge of Microsoft Office and Outlook

Detail oriented and organizational skills are a must

Basic computer software knowledge (Outlook and Microsoft Office a must)

Strong written, verbal and listening communication skills

Controlled issuance of batch records in preparation for manufacturing.

Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.

Assist functional areas with achieving timely and compliant final product disposition of the product.

Ensure Specifications in place and are within GMP compliance.

Organize and file all executed and associated GMP documentation (e.g. batch records).

Maintain batch documentation library (record check-in, check-out, follow-up, and distribution).

CAPA management as well as improving processes within QA Batch release.

Proven track record and practical experience with cGMP requirements.

Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.

2+ years of experience in a GxP Biopharmaceutical manufacturing operations. 1+ years of experience in a quality assurance role.

QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired.

Your responsibilities include, but are not limited to: