Sr Associate II, Quality Control Raw Materials

Biogen

Job Location:

Durham County, NC - USA

Monthly Salary: $ 93000 - 121000

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

This is a Mon-Fri day shift position fully on site

About This Role

The QC Sr. Associate II will have oversight of all activities associated with testing of raw materials and process aids manage projects write protocols and reports maintain robust and compliant cGMP documentation practices. The Associate will have a fundamental understanding of the Biogen Quality Systems and be able to apply it in their daily support functions. The incumbent willbe responsible foradherence to all GMP requirements a basic understanding of FDA/EMA regulations effective interactions/communication with Quality management personal development and support of investigations. This individual should be able to work effectively within the group as well as independently to meet assigned timelines. This role requires strong technicalexpertise excellent communication and the ability to work independently collaboratively within a team and across business functions.

WhatYoullDo

Perform scheduling of testing for raw materials and process aids
Ensuretimelycompletion of activities and track individual assignments
Execute testing to support release and/or investigation where applicable
Coordinate CLO submission forms and sample shipments
Support exceptions/investigations for the area
Support closure of Invalid Assays for the lab
Support cross-training program

Who You Are

You have a good understanding of the operating principles for quality control testing.The ideal candidate is naturally curious eager to learn asks thoughtful questions and does not accept claims without supporting evidence.Additionally you have excellent communication/collaboration skills logical thinking and can work across all levels of the organization.

Required Skills

Bachelors Degree(Life Sciences preferred) with5 years of experience working in a QC GMP environment
Quality Control testing experience to include compendial tests (pH osmo endotoxin total organic carbon conductivity etc) chemistry or microbiology related test methods
Direct root cause analysis experience with deviations laboratory exceptions etc including technical writing
Understanding of scientificprinciple ability to communicate with peers and management
Effective organizational skills
Ability to coordinate multiple activities in parallel to meetrequiredtimelines
Ability to work independently and as part ofateam
Demonstrated problem solvingskills

Preferred Skills

Advanced working knowledge of operations/quality systemsutilizedin QC operations/support teams
Advanced technical writing skills
Experience working with aseptic technique

Job Level: Professional

Additional Information

The base compensation range for this role is: $93000.00-$121000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.

Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:

Medical Dental Vision & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10000 per calendar year
Employee Resource Groups participation

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.

Required Experience:

Senior IC

This is a Mon-Fri day shift position fully on siteAbout This RoleThe QC Sr. Associate II will have oversight of all activities associated with testing of raw materials and process aids manage projects write protocols and reports maintain robust and compliant cGMP documentation practices. The Associa...