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Company

Original Job Post

Biogen · 1 week ago

Sr. Associate I, Quality Assurance

Triangle, NC

Full-time

Onsite

Mid Level

4+ years exp

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Comp. & Benefits

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Responsibilities

Batch Record Review impacting Product Disposition: Review all Quality related documents (e.g., production records, procedures, work instructions, raw data, in process testing, etc.) for compliance and determine acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.

Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of the investigations and provide feedback to the department owner. Support investigations with the ability to analyze the defect and determine potential areas within the process that may have attributed to the defect.

Controlled Document Workflows: Review of GMP controlled documents to ensure changes and reasons are accurately reflected in the workflow, content is compliant with all applicable regulations and company directives, changes will not have an adverse impact to product quality and setting appropriate release dates.

Execute activities including technical writing, investigation support (root cause analysis/impact assessment), and project representation.

Support resolution of both technical and compliance issues/gaps of moderate complexity. Help in implementation of Quality Systems/System Improvements and technical problem solving.

Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.

Control and release of equipment from maintenance, validation, change control and product changeover.

Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions.

Qualification

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Quality OversightFDA/EMA RegulationsManufacturing Process Knowledge Organizational SkillsDetail Oriented Aptitude Communication SkillsDownstream manufacturing operationBiologics

Required

Bachelor’s degree preferably in a field of science or biotechnology.

A minimum of 4 years relevant technical experience in quality oversight, preferably in a biotech or pharmaceutical manufacturing operation.

General understanding of relevant FDA/EMA regulations and compliance.

General understanding of the manufacturing process.

Strong organizational skills.

General understanding of Quality concepts; able to practice and implement them.

Ability to develop innovative/creative solutions to issues of moderate complexity.

Detail oriented aptitude.

Excellent oral and written communication skills.

Preferred

Experience in Downstream manufacturing operation.

Experience with biologics.

Additional years of experience in quality.

Company

Biogen

Glassdoor

3.8

Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.

Founded in 1978

Cambridge, Massachusetts, USA

5,001-10,000 employees

https://www.biogen.com/en_us/home.html

H1B Sponsorship

Biogen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (75)

2022 (131)

2021 (109)

2020 (112)