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Quality Assurance Manager, Finished Goods
675 Kendall St Cambridge, MA 02147 US
Job Description
Serve as QA representative for commercial finished goods and external manufacturing partners.
Represent Finished Goods Quality Operations at routine internal meetings and external contract manufacturers and for commercial production.
Oversee quality aspects of commercial finished goods specifications, qualification and validation, drawings, artwork, label, serialization, and packaging operations at CMOs for global commercial supply and ensure compliance to internal standards and regulatory requirements for US production.?
Review and approval of content within manufacturing partner and Alnylam Label and Pack documents, including BOMs, MPRs, Product Specifications, and Variable Data.
Ensure proper archival of manufacturing partner documentation in Alnylam’s document management system.
Manage Quality Records (deviation, capa, change control, serialization excursions, issue escalation) as it relates to commercial finished good assembly, label, and packaging activities.?
Recommend continuous improvement opportunities on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.?
Qualifications:
Minimum BS degree in life sciences, engineering, or related field.?
A minimum of 5 years of experience in a pharmaceutical or biopharmaceutical company.?
Experience with finished goods assembly, labeling, and packaging manufacturing operations at external manufacturers.
Excellent organizational, communication (written and verbal), and interpersonal skills.
Experience leading, training, and/or implementing root cause analysis and effective investigation practices.?
Pay ranges between $70-75/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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