Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
The candidate in this position is expected to create SOPs, batch records, protocols for the site Documents Management System. The Specialist will be working closely with cross-functional departments to ensure consistency of documentation practice within the site and across the company. The candidate should be able to lead meeting and take detailed meeting minutes.
This role will also be responsible to provide guidance and support to Analysts within the technical writing team. This specialist will also provide training to new team members. This role will be reporting to the Production Compliance Manager and will be working closely with the Deviation technical writing team. Previous experience in cGMP is required.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Create and/or revise SOPs, batch records, and various GMP documents in support of site operations.
• Lead team meetings and present trend data during tier meetings.
• Reduce un-necessary redundancy in procedures and GMP documents.
• Proofread, merge and format documents upon request.
• Perform biennial document reviews.
• Review and address comments on GMP documents.
• Participate and assist in site audits upon request.
• Work with cross-functional teams to drive documents closure and ensure consistency of documentation practices across the site/company.
• Site point of contact for global documentation process improvement initiatives.
• Train various teams on newly revised/effective procedures as well as train new team members.
• Support completion of department operational tasks to meet target KPIs.
• Assist in filing quality records extensions to ensure compliance.
• Assist in investigating deviations if needed.
• Track and trend all records related to documents change controls within the department/site.
• Provide routine updates on the status of all open records during tier meetings.
• Identify and resolve problems in collaboration with the management.
• Identify opportunities for improvement within scope of work.
• Adhere to company and global corporate policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.
Requires vaccination against different viruses including Vaccinia virus.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BS degree or equivalent level of skill and experience.
• Minimum of 2-4 years of technical writing experience in the pharmaceutical/biotechnology discipline.
• Expert in write technical procedures and documents relating to GMP operations with the following skills:
o Highly organized individual with strong attention to detail and great technical writing ability.
o Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand.
o Ability to manage time and priorities effectively.
o Ability to interface with others effectively at various levels in multiple departments.
o Ability to coordinate and lead meetings related to job function.
o Ability to work well independently and with minimum or no supervision and identify gaps within documents.
o High level of computer literacy, including MS Word and Excel.
o Ability to work extended and flexible hours (including weekends) when needed.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.