Tech Ops and Quality - Quality Assurance Manager, Finished Goods

LanceSoft Inc

Cambridge, MA

JOB DETAILS
JOB TYPE
Full-time
LOCATION
Cambridge, MA
POSTED
30+ days ago
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 Alnylams 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.

About the Company

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LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/