Technical Writer Job at LanceSoft in Frederick

Technical Writing Skill

• A Day in the life for this role might be 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. Technical writing experience is one of the required qualifications.
• Experience with CGMPs is essential.
• The primary focus will be writing and/or reviewing the various documents listed below.
• Experience with pharmaceutical/biopharmaceutical manufacturing is also required due to the regulatory expectations for pharmaceutical processes.
• Key terms to look for in a resume include Technical Services (TS) or Manufacturing Science and Technology (MSAT or MS&T). Strong candidates will also have experience with the following document generation: change control (CC), corrective action and preventive action (CAPA), and batch record (BR or MBR).

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.
• Experience coordinating and participating in interdepartmental project teams preferred.
• Knowledge of or experience with regulatory agencies and associated audits preferred.
• Knowledge of or experience with process validation preferred.

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