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Senior Manufacturing Documentation Specialist

Collagen Matrix Allendale, NJ
  • Expired: 19 days ago. Applications are no longer accepted.
About Collagen Matrix: Since our inception in 1997, Collagen Matrix has been awarded significant grant money for the research and development of collagen based matrix products. We have expanded into two facilities with nearly 200 employees and have commercialized over 50 medical devices for our five business units – Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair. Our products are now distributed around the world via a substantial global distribution network. Position Summary/ Objectives: The Manufacturing Technical Documentation Specialist II will be responsible for supporting the manufacturing operations by preparing, revising and organizing manufacturing documentation. This position ensures that the solid execution of company programs remain consistent with the overall company values. The ideal candidate has a solid understanding of the Manufacturing processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality. Essential Job Functions: Write and revise Batch Records and track through approval steps Write and revise Standard Operating Procedures (SOPs) and track through approval steps Write Engineering Change Orders (ECOs) and track through approval steps Write Process Deviations and track through approval steps Organize Validation, Equipment Qualification and Environmental files Participate in internal Quality Audits where needed Track training of personnel and "global" document changes through start of process to end of execution. Train personnel in the performance of their job GMP and ISO regulations. Perform other related duties and responsibilities as assigned or required. Initiate, recommend or provide solutions to streamline work-flow Qualify personnel to perform specific manufacturing tasks. Initiate, recommend, or provide solutions through designated channels. Assist with various special ad hoc projects and other duties as assigned Competencies: Business Acumen. Communication. Consultation. Critical Evaluation. Manufacturing Expertise Leadership & Navigation. Relationship Management. Ethical Practice. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds. Education, Experience and Certification: Bachelors’ degree in Engineering or a Science field highly preferred and 5-10 years of experience within a pharmaceutical or medical device company Experience in preparation of cGMP documentation is highly desirable. Experience with Microsoft software applications (Word, Excel, Power Point) Strong writing skills and ability to perform detailed document review Strong organization skills - ability to simultaneously track multiple projects Ability to manage change and grasp new concepts/processes quickly Knowledge of general cGMP requirements for an FDA-regulated production facility Excellent communication skills (oral and written). S Employment Type: Full Time Years Experience: 5 - 10 years Bonus/Commission: Yes

Collagen Matrix


Allendale, NJ
07401 USA