Overview
Construction Materials Laboratory Technician Jobs in Portland, OR at Intertek
About This Role
The Senior QA Associate II in the Quality Systems organization is responsible for understanding quality systems, contributing to oversight of quality systems, and maintaining GMP and laboratory activities at the Biogen RTP facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement.
The primary responsibilities of the Senior QA Associate II in the Quality Systems team include quality compliance for managing Drug Substance (Bio) Quality Systems, responsible as the Business Process Owner for the document issuance process, authoring Site Reports (Site Management Review Report), change control approval, deviation and lab exception approval, and the review and approval of site-specific GMP documents (Procedures, Work Instructions, Forms, etc.) for compliance to applicable regulatory and corporate guidance documents. In addition, this Senior QA Associate II will review/approve changes to existing Quality Systems and GMP processes, identify gaps in existing Quality systems, and propose solutions to site management.
What You’ll Do
Review and approve site-specific GMP documents and records. Assess and approve change controls, deviations, lab exceptions, and CAPAs for the RTP DS site
Business process owner of Document Issuance (Batch Production Records, Solution Lot Records, Logbooks (paper/electronic), and product labels)
Creation and Review of Site Management Review Reports and other site-based and department metrics
Identify and implement Quality System improvements
Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions
Additional job duties as assigned
Required Skills
Minimum Bachelor’s Degree required in Life Sciences or other technical discipline
Minimum 5 years’ experience working in quality within a GMP biotech or biopharma environment
Experience approving deviations, change controls, and lab exceptions is critical
Demonstrated leadership abilities and can lead complex problem-solving initiatives across functions or globally (coordinates activities across these groups to complete compliance activities)
Proficient understanding of internal quality systems and requirements
Strong oral and written communication skills; ability to communicate with senior management, peers and subordinates effectively
Strong organizational skills: ability to multi-task and coordinate multiple activities in parallel
Demonstrated troubleshooting and problem-solving skills
Knowledge of FDA/EMEA regulations and compliance
Preferred Skills
QA experience in approving OOS QC deviations strongly preferred
Analytical QC experience preferred
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.
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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Title: Construction Materials Laboratory Technician
Company: Intertek
Location: Portland, OR
