Compliance Specialist

1 month ago

Westborough, United States Astellas Pharma Inc. Full time
Responsibilities include, but are not limited to, the following:Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records. Identifies and reports documentation errors and deviations from SOP or specifications in a timely manner. Tracks basic metrics on reviewed documents to support monthly reporting.Assists with the Deviation and Corrective / Preventive Action (CAPA) programs, aids investigations, and may assume investigation leader status for select deviation investigations. Helps ensure that deviation records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment. May assist with monthly metrics and continuous improvement opportunities for these programs.May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic/international GMP regulations.Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large.Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new compliance requirements or improve work practices.May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring information requests, reviewing CMO work, and following up on other compliance items.

Quantitative Dimensions:

This position will provide a direct and positive impact on the compliance of the products, equipment, facility, methods, and systems supporting current and future AIRM manufacturing processes. AIRM processes will be compliant with the strictest international regulatory standards and meet Astellas’s uncompromising focus on Quality and Integrity.

Organizational Context:

The Compliance Specialist reports to a Associate Quality Assurance Manager or Quality Assurance Manager, who in turn reports to the Director of Quality Assurance. Quality Assurance forms one element of the organization’s “Technical Operations” team, complementing and joined by Manufacturing, Quality Control, Engineering, Materials Management, Product Development, and Translational Development.Position is organized for a work schedule of 2nd shift Monday – Friday 11:30 a.m. - 8:00 p.m. In very rare instances where QA coverage is needed on weekend days or evenings, these duties will rotate within the team and be negotiated with management in advance. GMP Operations at AIRM support cell culture manufacturing platforms, which naturally runs 7 days per week.  Requirements

Required:

BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.Working fluency the Microsoft Office productivity suite (including Excel and PowerPoint).

Preferred:

Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.Specialized knowledge of any industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)

Benefits:

Medical, Dental and Vision InsuranceGenerous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks401(k) match and annual company contributionCompany paid life insuranceAnnual Corporate Bonus and Quarterly Sales Incentive for eligible positionsLong Term Incentive Plan for eligible positionsReferral bonus program

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