Investigations Specialist - Lancesoft : Job Details

• Job Posting Qualifications:
• Bachelor's degree in chemistry, biology, engineering, or related life science field; or an equivalent combination of education and related experience
• 4+ years relevant experience required
• Technical writing experience required
• Prior experience with large-scale pharmaceutical or biopharmaceutical manufacturing unit operations
• Prior experience in a GMP manufacturing facility

Technical writing skill

• A Day in the life for this role might be a little bit varied, but it will mostly include writing and reviewing batch records for GMP oligonucleotide pharmaceutical manufacturing, writing and reviewing change controls for these processes, and collecting and evaluating manufacturing batch data. I think this is why technical writing experience is one of the required qualifications.
• Needs to have experience with CGMPs.
• Primary focus will be writing and/or reviewing the various documents listed below.
• As for qualifications that are negotiable, I think the required elements listed below are all indeed required. For a temporary position, too, I would almost say that experience with pharmaceutical/biopharmaceutical manufacturing is also required. It would be challenging to get someone up to speed on the regulatory expectations for pharmaceutical processes in the limited time currently projected for the role.

Some of the key words that I would definitely want to see in a resume are Technical Services (TS) or Manufacturing Science and Technology (MSAT or MS&T) as these are all direct analogues to the current role. Another thing that would differentiate a strong candidate would be experience with some of the following document generation: change control (CC), corrective action and preventive action (CAPA), and batch record (BR or MBR).