Description
Recipharm is a leading contract development and manufacturing organization (CDMO) in the pharmaceutical industry employing 9,000 employees with headquarters in Sweden. One of Recipharms nine research and development facilities is in Research Triangle Park, North Carolina, USA. Recipharm Laboratories aspires to be the first-choice strategic partner for inhaled drug development companies worldwide. We are seeking a Technical Writer for our RTP team. In this role, you will work with Scientific Project Leaders, Analysts, Quality Control and Quality Assurance teams to author and facilitate the review of a variety of client deliverables, including Product Development Reports, Investigative Study Reports, Method Transfer and Validation Reports, Investigations, and other Product, Method and Quality related Documentation including Deviations, Change Controls, and CAPAs. In this position, your key responsibilities will be as follows: Ability to author and review technical documents (batch records, standard operating procedures, forms, reports, protocols, specifications, methods, COAs, etc.) with tenacious attention to detail and consistency Support the creation and processing of quality records including laboratory investigations, deviations, Change Control, and CAPAs Ability to author and review quality records including Laboratory Investigations, Deviations, Change Control, and CAPAs with minimal guidance. Ability to author and review study protocols and reports of varying complexity for activities including, but not limited method validation, method transfer, product release, and stability with minimal guidance. Ability to author and review various types of documents related to analytical equipment onboarding and qualification, including, but not limited to URS, IQ/OQ/PQ, change controls. Assists in technical training of staff, as needed. Ability to interact directly with customers or with regulatory agencies, as needed. Create, maintain and update policies, data entry materials, training materials, and other technical materials in accordance with applicable laws and company/site standards. Contribute to the completion of projects and milestones. Gather inputs and collaborate with the team for areas where the technical writer is not the SME. Required Qualifications: Bachelors degree in Science (Chemistry, Biology, or related science) 5+ years of experience in a technical writing role in the pharmaceutical industry environment is required. Ability to interact and build relationships with individuals at all levels Adept at translating technical and scientific information Excellent communication skills (oral and written). Experience working both independently and in a team-oriented, collaborative environment is essential. Additional preferred Qualifications: Pharmaceutical CMO/CDMO experience with Customer interaction Previous experience in inhalation and/or analytical laboratory We offer a competitive compensation and benefits package including: Full Benefits (Medical, Dental, Vision, Life, Disability) 401(K) with Company Match Paid Vacation & Sick Time Dependent Care FSA Educational reimbursement program **Relocation assistance is not provided for this position.** COVID-19 considerations: Per local mandate, masks are required on site. Vaccinations strongly recommended for all adults.
