Associate III Quality Control Investigations

About This Role

The Associate III is responsible for supporting leading/participating in team initiatives regarding compliance documentation writing deviations and environmental excursions. Drive CAPA and periodic review activities with the ability to follow through. Ensures all work is carried out in a cGMP manner with adherence to regulatory regulations. Provides support for operations/testing process equipment and test methods as well as practical knowledge of current regulations and cGMPs are needed to perform this position effectively.  

What Youll Do

• Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured as applicable for laboratory deviations and exceptions
• Author technically sound simple to moderately complex reports with minimal guidance
• Support laboratory operations and actively communicate across functional groups for completion of deliverables
• Initiate and monitor QC laboratory documentation such as Standard Operating Procedures methods and periodic review of laboratory procedures and see them through to completion
• Participates in process improvements supports management and QC teams

Who You Are 

You are passionate about solving technical compliance gaps and areas for improvement or remediation related to quality or process. You are confident in making decisions that have potential compliance impact to methods results product and/or quality systems. You work effectively independently and within a team framework across business and multiple levels. 

Qualifications :

Required Skills

• Bachelors degree preferably in a field of science or biotechnology 
• A minimum of 2 years relevant experience in Quality Control in a GMP biotechnology or pharmaceutical manufacturing environment 
• Experience conducting investigations (in lab environment preferred) 
• Good working knowledge of operations/quality systems understands work processes of QC operations/support teams (e.g. strong test method/scientific base) 
• Excellent technical writing skills; authors technically sound simple to moderately complex reports and complex reports with limited guidance 

Preferred Skills 

• Proficient in Trackwise LabWare and LIMS 

Additional Information :

The base salary range for this position is $annually. 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 longterm 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 wellbeing; including but not limited to:

• Medical Dental Vision & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short and LongTerm Disability insurance
• A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 on to 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 EVerify Employer in the United States.