Sr Associate QA - Days

Initial Therapeutics, Inc.; West Greenwich (RI); On-site; USD 70,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Discretionary annual bonus

Retirement and Savings Plan

Job summary

Amgen is seeking a Sr Associate QA to provide on-the-floor quality oversight during manufacturing activities, ensuring compliance with cGMP, GDP, and related regulations. You will work with Manufacturing, Quality Control, and Facilities/Engineering staff to maintain quality and drive improvements.

The role requires coordinating documentation, reviewing records, and guiding deviations and investigations while supporting training and continuous improvement efforts within a fast-paced production

Qualifications

• High school/GED plus 4 years QA/manufacturing experience.
• Associates + 2 years QA/manufacturing experience.
• Bachelor's + 6 months QA/manufacturing experience.
• Master's degree in a related field.

Responsibilities

• Provide Quality oversight to ensure products are manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations.
• Provide Quality oversight during on-the-floor analytical testing.
• Ensure facilities, equipment, materials, processes, and procedures follow cGMP and applicable regs.
• Investigate and document deviations per procedures.
• Ensure production records and test results are complete and documented per written procedures and cGMP.
• Review and approve cGMP processes, SOPs, batch records, deviations, and logbooks.
• Author, review, and approve quality documents such as risk assessments and protocols.
• Alert senior management of potential risks to quality, compliance, supply, or safety.
• Complete assigned training to perform tasks.
• Drive operational improvement initiatives and projects.
• Perform other tasks to support group/department goals.

Skills

Quality Assurance

Manufacturing

cGMP compliance

Documentation

Education

Bachelor's degree

Associate's degree

Master's degree

High school Diploma or GED

Tools

Microsoft Office

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Associate QA

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.

Responsibilities Include:

• Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.

• Provide Quality oversight during on-the-floor analytical testing.

• Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.

• Ensure that deviations from established procedures are investigated and documented per procedures.

• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

• Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.

• Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.

• Alert senior management of potential quality, compliance, supply, or safety risks.

• Complete assigned training to permit execution of required tasks.

• Drive operational improvement initiatives, programs, and projects.

• Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The agile professional we seek is a good collaborator with these qualifications.

Basic Qualifications:

• High school/GED + 4 years Quality Assurance or manufacturing work experience OR

• Associates + 2 years Quality Assurance or manufacturing work experience OR

• Bachelors + 6 months Quality Assurance or manufacturing work experience

• Master's

Preferred Qualifications:

• Experience working in a cGMP environment

• Experience with decision making

• Experience with analytical testing and/or general compendia testing

• Experience working with batch records and other GMP documentation

• Knowledge of data integrity requirements

• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)

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, well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

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.