(R-RDTW) Location: Rochester, Michigan Description: In partnership with Product Development staff, Program Management, Manufacturing, Quality and Validation, embrace right first time (RFT) and continuous improvement (CI) expectations, whilst minimizing time to market (TTM).
Prepare new, maintain and revise controlled documentation. Controlled documentation includes but is not limited to the following document types: master batch records, test procedures, specifications, protocols, standard operating procedures, work orders, training guides, reports and NDA/ANDA filing documentation.
The essential functions of the position include, but are not limited to:
- Follow departmental Standard Operating Procedures and assists department management in the update and maintenance of departmental Standard Operating Procedures.
- Collaborate with Scientist, Customers, Operations, and Regulatory Affairs personnel to generate controlled documentation; master batch records, test procedures, specifications, protocols, standard operating procedures, work orders, training guides, reports and NDA/ANDA filing documentation .
- Work effectively with department members to ensure that specific requirements with respect to protocol and report content are met.
- Prepare Technical documents for customer and MCP FDA filings.
- Prepare technical documents to reduce misunderstanding and drive standardization within documents across Product Development.
- Support the Product Development audit response team as needed.
- Handle assignments as necessary to meet company objectives and contract customer commitments.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor of Science Degree required in Science, Life Science, or related technical field or equivalent.
- Greater than 3 years’ experience in a pharmaceutical environment.
- Previous experience within Research and Development a plus.
- Excellent written, editing and communication skills required.
- Proven scientific/technical writing skills required.
- Strong organization skills, attention to detail and ability to multi task.
- Previous cGMP/GLP experience.
- Advanced computer skills (Microsoft Word and Excel).
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter and Apply Online
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