Sr Associate, Manufacturing (Technical AuthoringDeviation Investigations))

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

Sr Associate Manufacturing (Technical Authoring/Deviation Investigations)

What you will do

Lets do this. Lets change the this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOPS) protocols technical reports and training material in a GMP regulated environment that supports the manufacturing process.

• Develop review and update technical content including but not limited to standard operating procedures work instructions risk assessments protocols & reports for manufacturing team.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation collation of data and tracking of technical documents.
• Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and / or troubleshooting projects.
• Support manufacturing team in reducing document turnaround times.
• Ensure documentation related actions are completed on time and current schedule is maintained accurate and up to date.
• Develop protocols for Manufacturing to support change controls deviations & troubleshooting investigations with provision from relevant SMEs.
• Generate own and provide subject matter expertise to Quality System records as minor deviations CAPA complaints and change control records.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

We are all different yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.

High school/GED 4 years in Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

OR
Associates 2 years years in Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

OR
Bachelors 6 months years in Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

OR
Masters

• Educational Background in Science and/or Engineering.
• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Dynamic skills and usage of photographs drawings diagrams animation and charts that increase users understanding.
• Experience supporting deviations investigations CAPAs and change controls.
• A fact-based problem solver with strong troubleshooting and problem-solving skills.
• Pro-active with the ability to prioritize work to meet benchmarks
• Good documentation and communication

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.

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.

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 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.

Salary Range