Manufacturing Compliance Associate
Posting ID: JP-002630621
Long term opportunity in a newly created debarment with our rapidly growing CMO client! If itnerested, please send your resume to email@example.com
The Manufacturing Compliance Associate position is responsible for supporting all compliance (Quality and Safety) investigations and corrective actions, as well as the origination and revision of quality documentation in support of the Manufacturing group. This person will work with Manufacturing managers, supervisors, and leads to assure the growth and maintenance of a quality and safety compliance culture.
• Facilitate, document, and review compliance related investigations to ensure root causes are identified, corrective actions implemented, and the effectiveness of these corrective actions fulfill regulatory and business requirements.
• Support project team with originating and revising manufacturing related SOPs and batch records.
• Supports audits of all quality and safety compliance systems including safety analysis/risk assessment, 5S, training, documentation, and general manufacturing operations to assure continual compliance.
• Would support on time performance within the department using visual management tools.
• Support training opportunities for manufacturing staff in the areas of quality and safety compliance.
• Provide technical writing support for quality investigations and assure standards for investigational reporting are met.
Additional Skills & Qualifications:
• A BS in a technical discipline is required, Chemistry, Biology, Engineering preferred.
• 3-5 years of experience in a cGMP pharmaceutical manufacturing environment with demonstrate experience writing investigations and other quality documents.
• Experience leading departmental and cross-functional teams through effective peer-to-peer influence is strongly recommended.
• Lean/SS certification is preferred.
• Must have strong technical writing and communication skills.
• Experience leading root cause analysis is strongly recommended.
• Must be experienced with standard Microsoft business applications and proficient with Excel graphing tools. Knowledge of statistical software tools is preferred,
The person in this role must be familiar with requirements working in highly regulated industry to understand compliance standards and requirements. This person must also work effectively in a cross-functional peer-to-peer environment to drive continuous improvement activities to successful outcomes.
This role is accountable for assuring that all manufacturing operations are compliant with all relevant regulatory guidance including but not limited to FDA, OSHA, EPA, and state regulatory requirements. The person will accomplish this by working collaboratively with various cross functional team to assure departmental goals are met.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072