Biogen
Sr Associate II, Quality Control Investigator
Biogen, Durham, North Carolina, United States, 27703
What You'll Do
The Sr Associate II will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, actions, and environmental excursions. The Sr Associate II must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations.
Responsibilities
Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions
Author technically sound moderately complex reports with minimal guidance
Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables
Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion
May provide Quality Unit (QU) approval for minor deviations, lab logbooks, and Analytical Instrument Validation (AIV) reports
Participate in process improvements, supports management and QC teams
Other duties as assigned
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, products, and/or quality systems. You work effectively, independently and within a team framework across business and multiple levels.
Required Skills
Bachelor's degree, preferably in a field of science or biotechnology
A minimum of 5 years’ relevant experience in quality oversight of a biotechnology or pharmaceutical manufacturing operation
Thorough understanding and demonstrated expertise in conducting investigations in a biotech or pharma GMP environment within Quality Control labs
Good working knowledge of operations/quality systems underlines 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, LIMs, Kneat, and Veeva
Job Level Professional
Additional Information The base compensation range for this role is: $91,000.00-$118,000.00
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.
Benefits 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 $10,000 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 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 E-Verify Employer in the United States.
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Responsibilities
Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions
Author technically sound moderately complex reports with minimal guidance
Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables
Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion
May provide Quality Unit (QU) approval for minor deviations, lab logbooks, and Analytical Instrument Validation (AIV) reports
Participate in process improvements, supports management and QC teams
Other duties as assigned
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, products, and/or quality systems. You work effectively, independently and within a team framework across business and multiple levels.
Required Skills
Bachelor's degree, preferably in a field of science or biotechnology
A minimum of 5 years’ relevant experience in quality oversight of a biotechnology or pharmaceutical manufacturing operation
Thorough understanding and demonstrated expertise in conducting investigations in a biotech or pharma GMP environment within Quality Control labs
Good working knowledge of operations/quality systems underlines 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, LIMs, Kneat, and Veeva
Job Level Professional
Additional Information The base compensation range for this role is: $91,000.00-$118,000.00
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.
Benefits 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 $10,000 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 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 E-Verify Employer in the United States.
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