Quality Assurance Lead
Boston Metro Area, MA
Government Funded Requisition
-Knowledge of Government Contract execution and compliance with the Federal Acquisition Regulations (FARs)
-Make sure that if you have a candidate, that the travel expenses you offer or agree to are in compliance with the FAR s
-The fees charged and the invoices submitted to SP for the work/equipment shall be in conformance with the Federal Acquisition Regulation ( FAR ) clauses attached to this Purchase Order and including FAR 31.205-46 (TRAVEL). If Per Diem is to be used, Daily Per Diem should be in conformance with the Federal Acquisition Regulations.
1. Investigate events/ non-conformances encountered during GMP operations, such as manufacturing, testing or holding of drug products. Partner with operation; work on the shop floor and in a team environment to provide on the spot input and guidance in responding to deviations. Lead investigation teams. Make recommendations to department management regarding results of investigation and process improvements, when necessary. Work with impacted department management to identify appropriate corrective and preventive actions.
2. Assist in tracking of CAPAs through completion.
3. Ensure a constant state of inspection readiness ensuring that deviation and CAPA documents remain current.
4. Provide support during internal and external audits and ensure that assigned audit observations are addressed quickly and completely to maintain readiness levels.
5. Perform CGMP audits, as necessary. Identify and communicate CGMP compliance deficiencies to Upper Management, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are implemented.
6. Provide final signatory review for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with CGMP, regulatory and internal requirements such as company guidelines and approved procedures.
7. Perform special projects as assigned by supervisor.
Experienced investigator able to effectively investigate medium and high risk events
A strong customer focus and ability to prioritize and adapt to compliance and business needs are required Experience in maintaining CGMP compliance
Excellent organizational, analytical, and problem solving skills
Balanced decision making skills
Strong communication skills with the ability to interact with all levels throughout the organization
In addition, demonstrated excellent interpersonal skills and flexibility
Must have understanding and/or working knowledge of CGMP regulations
The ability to apply quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities
The ability to Work effectively and efficiently in a cross functional team environment
Must be able to work strategically in a fast paced environment and make balanced decisions related to quality.
Experience interacting with regulatory agencies and health authority inspections is preferred
Excellent organizational, interpersonal and leadership/teamwork abilities are required
Strong GMP background including working knowledge of GLP/GMP
Diverse business, quality, and industrial manufacturing knowledge base
Master s Degree of Science in Engineering or Life Sciences and 5 year of relevant industry experience
Bachelor s Degree of Science in Engineering or Life Sciences and 7 years relevant industry experience
12+ years relevant industry experience
Demonstrated experience with MS Office Applications
1. Significant experience leading Problem Solving and Process Improvement teams
2. Must have a minimum of 5-7 years of relevant experience within Quality, Compliance, or manufacturing
3. Must have previous biologics, biotechnology, pharmaceutical or biopharmaceutical experience.