Sr. Associate Plant QA 12 Night Shift (6pm- 6:30am)
New Albany, Ohio, United States · On-site
$82k–$111k/yr
Mid level$29B raised
Career CategoryQualityJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious ill…
Skills: Quality assurance, GMP, Batch record review, Compliance, Standard operating procedures
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Turner & Townsend
Construction Safety Facilitator - Data Center (Mid-Atlantic/East Region)
New Albany, Ohio, United States · On-site
$150k–$165k/yr
Senior
Company Description Turner & Townsend is a global professional services company with over 22,000 people in more than 60 countries. Working with our clients across real estate, infrastructure, energy and natural resources…
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$82k–$111k/yr
Full-time
high school, associate degree, bachelor degree
Health insurance, Dental coverage, Vision coverage, Life insurance, Disability insurance, Retirement and savings plan
Posted 2d ago
Apply by Sep 16
~40 hrs/week
Responsibilities
The Senior Associate Plant QA provides quality guidance and support to production operations, including performing batch record reviews and ensuring compliance with GMP standards. They act as a primary contact for quality-related queries and oversee documentation such as SOPs, deviations, and change controls.
Requirements
Candidates must have a high school diploma or GED with 4 years of experience, an associate degree with 2 years of experience, or a bachelor's degree with 6 months of experience in Quality or GMP manufacturing. Preferred qualifications include a scientific degree and experience with regulated industry operations and digital quality systems.
Full job description
Career Category
Quality
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Sr. Associate Plant QA Night Shift
What you will do
Let’s do this. Let’s change the world. In this role As Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed at AOH. Next to that, you will provide support in different QA related projects/systems.
In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering.
Responsibilities
Let’s do this. Let’s change the world. In this vital role you will:
Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
Perform finished product checks during (commercial) production runs
Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.
Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
Review and approve Deviation, CAPA, and Change Control records.
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives
Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with any of these qualifications.
Basic Qualifications:
High school/GED + 4 years of Quality and/or GMP Manufacturing experience
OR
Associate’s + 2 years of Quality and/or GMP Manufacturing experience
OR
Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
OR
Master's
Preferred Qualifications:
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Experience in and knowledge of GMP/GCP operations or similarly regulated industry
Affinity with digital innovation, data sciences and Quality engineering
Experience with raw material receipt, inspection & sampling
Highly effective verbal and written communication skills, strong interpersonal skills
Great attention to detail and high degree of accuracy in task execution and GMP documentation
Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
Strong organizational skills, including ability to follow assignments through to completion
Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
82,081.95USD -111,052.05 USD
Related keywords
Quality AssuranceGMPBiotechManufacturingBatch Record ReviewSOPCAPAChange ControlLean TransformationOperational ExcellenceSAPTrackWiseCDOCSComplianceQuality EngineeringData Science
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
How much do Engineering jobs in New Albany, OH pay?
Based on 129 listings with disclosed salaries, most engineering jobs in New Albany, OH pay between $55k–$166k per year. Individual offers vary with seniority, company size, and specialization.
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There are currently 230 open engineering positions in New Albany, OH listed on Clera. New openings are added daily as companies post roles.
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Companies currently hiring include Amazon, American Electric Power, Amgen, Williams, American Regent, Inc., among others. Browse the listings above to see every active employer.
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