The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.
Applicants must be legally authorized to work in the United States. Sponsorship not available.
Our client is seeking a QA Associate in Newport Beach, CA.
Skills & Requirements
• Education: BA/BS in chemistry or science-related field preferred, or equivalent from two-year college or technical school; a minimum of Two-year related experience and/or training; or equivalent combination of education and experience.
• Experience: A minimum of 2 years of experience in Quality including cGMP and ISO standard.
o Experience of cGMP and MS Word, PowerPoint and Excel.
Who you are:
• Knowledge of Quality Assurance/Quality control/Operations in a regulated environment
• Familiar with lab equipment operation and set-up.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports and procedures.
• Ability to successfully present information and respond to questions from groups of managers, clients, customers, and the public.
• Great Teammate and good social skills
• Must be able to interface effectively with all levels of the company employees
How you will thrive and create an impact
• Issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule.
• Issuance of controlled labels used for labelling finished goods and other related samples.
• Monitor the equipment program including calibration and preventative maintenance timelines and complete quality assurance sign-off for equipment workorders.
• Issuance and reconciliation of equipment and room logbooks.
• Coordinate the release of raw materials after completion of review and approval of supporting documentation including supplier and quality control testing records.
• Conduct reconciliation, filing and archiving of all quality-controlled records. Store completed documents in the appropriate data files and coordinate off-site document storage with third party as necessary.
• May provide pre-run line clearance to manufacturing.
• Consult with document originators to resolve discrepancies.
• Work closely with internal departments to assure commitment to customer is met in a timely manner.
• Management of Label Program. Includes development of master labels, maintain controlled label stock, setting inventory safety stocks, printer supplies, and coordinating reorders.
• May provide batch record review support.
• Writing and revising SOPs as part of process improvement initiatives or as needed to support the department.
• Coordination of document control activities and delegating with other quality coordinators to drive workload completion at the direction of quality management.
• Actively participate and drive the quality and safety culture of the site.
• Performs other duties as assigned
Environment
• Typically works in an office environment with adequate lighting and ventilation and a normal range oftemperature and noise level. May also work in warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on product.
• Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
• A frequent volume of work and deadlines impose strain on routine basis.
• Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
Benefits/Other Compensation
This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.
Drug testing may be required; please contact a recruiter for more information.
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