Quality Assurance Operations Specialist Jobs

Data collection, management and analysis

Ensure that all products and processes meet internal and external stakeholder requirements.

Experience in the process of Coverage Determinations in Healthcare

Communication skills - verbal and written

Audit Individual Operations team members on processes

Coach team members for improvement against quality metrics

Lead all activities involving quality assurance and compliance with applicable contract requirements, conducting audits and reviewing/analyzing data, deliverables, and documentation.

Experience in creating and implementing a detailed plan to ensure overall quality of IT products, services and systems.

Experience in resolving project or programs problems and take corrective action, escalating as needed, to resolve and achieve results.

Experience in reviewing and, if needed, correcting the functionality and effectiveness of essential tools.

ServiceNow reporting experience in addition to Splunk, Tableau, Power Bi and other data visualization tools.

Knowledge of basic WAN and LAN network architectures.

Minimum of 5 years People Management experience

Ensures proper training and qualification of all Operational quality assurance associates in team.

Minimum of 7 years experience in the pharmaceutical or relevant industry experience

Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience

Related experience in supporting an operational quality assurance team

Familiar with Lab equipment Validation/Qualification Master Plan &Protocols is desired

Manage material disposition for commercial and clinical trial materials.

Manage the review of product release and stability data.

Possess a scientific degree (BS) and have at least 5-8+ years of experience in the pharmaceutical/biotech industry.

5+ years of experience in Quality Assurance.

Preferred experience with topical and liquid dosage forms.

Provide quality oversight for contract manufacturing operations of drug substance and drug product, both for commercial and clinical trial materials.

Experience with using Quality Risk Management principles.

Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry.

Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.

Ability to adapt to changing priorities and manage multiple assignments while meeting timeline.

Three (3) plus years of related experience in a regulated industry (vaccine, biologics, pharmaceutical)

Two (2) years of quality or GMP experience within a manufacturing organization

Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.

Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.

Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

Continuously looking for opportunities to learn, build skills and share knowledge with others.

Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.

Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions.

Generates reports as requested by management (i.e., accuracy, quality).

Intermediate computer skills (e.g. Microsoft Office, Outlook, Internet search) and experience with health care systems and documentation (EMR, billing and claims).

Strong analytical and problem-solving skills.

Demonstrated experience with writing, documentation, and editing.

One-time furniture and equipment allowance for employees working from home

Remote within WA, ID, OR, and UT

6.1 Formal Qualifications and Experience

Job Specific skills and abilities

Acquire and continuously update knowledge of operations and equipment, instrumentation, operation processes, etc.

Overall accuracy and thoroughness; knowledge of the quality system

Basic presentation skills to demonstrate the lab equipment and quality processes during customer visits and audits.

Troubleshooting skills to assist in implementing solutions to resolve corrective actions

Project Management experience a plus

Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.

Write and/or revise controlled documents in support of job responsibilities.

Training and work experience in root cause analysis tools (Isikawa) and statistical analysis (TQM, SAS) required.

We are looking for professionals with these required skills to achieve our goals:

Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.

Support the execution and implementation of a Corporate Quality Management System (QMS) software

Knowledge of cGMP requirements and FDA regulations would be a plus.

Manage inspections of goods as well as segregation and quarantine of defective items until the disposition of the product is determined

A minimum of 3 years experience in the pharmacy industry, pharmacy technician experience is extremely relevant

A minimum of 3 years experience in the area of Quality Assurance/Control, Warehouse Operations, and/or Compounding

Ability to effectively present information, identify problems and resolution to address questions from managers, clients, customers, and regulatory agencies

Ensure label requirements for each country are defined

8 years professional work experience in regulated industry with Bachelor's degree, or 10 years' experience with Associate’s degree

8 years professional experience in Quality role in pharmaceutical or biotech company

Ensure overall compliance of Clinical and Commercial products for all regions

Ensure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and Recalls

Support product launch activities for introduction of product into new countries

Work Control and Outage Management - Investigate problems experienced in the work management area. Make decisions and guide solution implementation.

Apply well-developed leadership skills, including setting high standards and managing accountabilities.

Assist Operations Management by applying Operations expertise for the following:

Maintenance - Provide Operations leadership and experience for the development and implementation of effective and safe maintenance programs.

Drive highly experienced actions, with considerable latitude for independent action with minimum supervisor direction.

Deal authoritatively and effectively with plant personnel at all levels, contractors and loaned employees, exhibit listening skills, and negotiate diplomatically.

Demonstrated management and collaboration skills

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS

Complete competency with electronic document managements systems and other information management system

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Develop metrics and run the Quality Management Review process for clients and Memphis Operations.

Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry. 15 years experience is preferred

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Ensure the quality policy and objectives are understood, implemented, and maintained at all levels of the organization.

Develop short and long-term plans to achieve both quality and business objectives.

Provide guidance, support and oversees all activities related to batch record review and product disposition for internal Manufacturing at Moderna Inc.

Strong relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.

Thorough understanding of biotech/pharmaceutical manufacturing cGMP, regulatory obligations and quality management principles.

Experience using risk-based thinking or risk-based tools required. Strong analytical abilities necessary.

Practical understanding of principles of project management and team facilitation.

Manages execution and supports design of Department Training Plan(s).

Oversees investigations/CAPA managed by Quality Operations and CAPA processes

You have working knowledge of statistical methods and computer skills

You have at least 2 years’ experience in quality related processes

You have advanced knowledge of the principles and techniques of microbiology and chemistry

You exhibit knowledge of laboratory equipment, instrument maintenance, calibration and trouble shooting

Possess a proven track record of achievement in a high speed, high volume manufacturing environment

Demonstrable evidence of driving World Class Supply Initiatives to deliver on challenging objectives

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including: