Manufacturing Quality Assurance (QA) Analyst, Albuquerque, NM
Schedule/Shifts: 3x12 shifts, 3 days on / 4 days off, 6:00am-6:30pm, and 6:00pm-6:30am
Relocation Assistance available for the right candidate!
The Manufacturing Quality Assurance (MQA) Analyst will be and essential part of the Business Unit's management team. The MQA Analyst will assist in management of the daily activities of the Business Unit, but will report independently to the Manager of MQA. The MQA Analyst will be responsible for providing direct Quality Assurance support to the Manufacturing shop floor. The MQA Analyst, with direct supervisory guidance, will be responsible for a diverse and challenging set of activities, all of which are related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international GMP regulations and guidance's.
Essential Duties and Responsibilities:
- Performing line clearances and line monitoring.
- Having a basic knowledge of problem solving techniques and demonstrating the ability to troubleshoot with limited supervision
- Verbally express ideas, facts and proposals that are clear, logical, and concise manner.
- Recognizing atypical data and reporting it to the appropriate supervisor or designee
- Able to work effectively with other departments, coworkers, and QA teams
- Being proficient at technically reviewing/auditing shop floor records and reports such as logbooks and other types of documentation for completeness and accuracy.
- Assisting MQA Specialists or MQA Snr Manager to identify technical problems and provide guidance and support to real time shop floor quality issues up to and including: making real time product impact assessments, and go no go decisions
- Participating in quality systems implementation and maintenance efforts to ensure alignment with business process needs and user requirements
- Awareness of changes impacting internal SOPs, recommending modifications for SOPs and author, review and edit documents, protocols, and problem reports
- Working with the Quality Compliance and QAPS group to evaluate deviations related to production batches, the laboratories, or the facility.
- Working with the QA Product Specialists to support customer issues, investigations, corrective actions and change controls.
- QA operates 24 hours a day, 5 days a week for production support.
- Other duties as assigned
- Bachelor's degree (B. S.)
- Minimum of 4 years' experience, preferably in an aseptic manufacturing environment
- Excellent Communication skills, both verbal and written
- Ability to organize time in order to successfully manage multiple projects and priorities
- Ability to read, understand, interpret and implement technical writing and instructions.
- Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals
- Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.
- Willing to be on call to answer questions from production 24 hours / 5 days a week.
- Root cause analysis trouble-shooting experience.
- Knowledge of aseptic processing technique.
- Ability to train and advise QA professionals and production personnel.
- Ability to assess and review all regulated product-specific documentation.
- Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly. Ability to speak effectively.
- Mathematical Skills: Ability to apply basic math concepts.
- Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Computer Skills: Proficient in the use of MS Word, Excel, Outlook and Access, as this individual will perform work within these systems on a routine basis.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.
Questions? Contact Kevin at firstname.lastname@example.org or call at 623-688-2142
Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website