Position Summary: Writes, edits and reviews cGMP manufacturing documents, product specifications, Standard Operating Procedure (SOP), batch records (BR), risk management documents, Finishing reports, and investigations.

Essential Job Functions:

• Writes and edits SOPs, BRs, investigations and other related documents

• Works with Finishing personnel to re-write, clarify or reconstruct controlled documents and investigations

• Verifies that all SOPs and specifications are up-to-date and reflect current procedure

• Participates in the Quality system root cause investigations associated with nonconformances and complaints

• Supports investigation teams as a Finishing area subject matter expert

• Conducts and prepares investigation reports

• Participates in Site Investigation teams

• Recommends and implements root cause analysis and CAPA plans

• Provides support for the management review of investigations and CAPAs

• Assures overall compliance with internal specifications, customer/partner specifications, and FDA regulations

• Develops and maintains Finishing performance metrics

• Follows all company Environmental, Health and Safety policies, procedures and guidelines, and conducts work in a safe manner

• Performs other duties as assigned

Job Specifications (skills, knowledge, special training, certification, license requirements):

• Excellent scientific and technical writing abilities and advanced computer skills experience in the biotech industry for CAPA/investigations, product quality reports, technical reports

• Strong PC skills including

• Excellent communication skills interacting with Manufacturing staff, supervisors and members of other departments as appropriate to ensure prompt resolution of problems

• Well organized and detail oriented with a focus on correct component, labels and documentation

• Ability to work in a high pressured, deadline-oriented environment

• Excellent attendance required

Education and Work Experience Required:

 

• Bachelor's degree

• GMP experience working in a regulated environment (FDA, ISO, etc.)

• Experience working in medical device product manufacturing environment

• Experience with root cause investigation, Corrective/Preventative Action development, Supplier Corrective Action Request reporting (SCAR), and process qualifications

• Experience with standard operating procedure (SOP) and batch record development and revision

The base salary range for this position is $62,500- $68,000/year.  The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

We offer a competitive benefits package that starts on day one, including medical, employer-paid dental & vision, 401(k) match up to 5%, and generous PTO and holiday benefits.  The typical work schedule consists of half-day Fridays.

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer