Sr. Microbiology Technical Writer I

Why join Ajinomoto Bio-Pharma?

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Sr. Micro Technical Writer I who is responsible for the completion of investigations for the Microbiology Department, including the review and approval of deviation, out-of-specification, and action level excursion investigations (with a focus on clinical lots and facilities). The Sr. Micro Technical Writer I authors DRs, OOSs, ACTs, SOPs, protocols and reports.

Responsibilities:

· Serves as department technical writer for investigations, including but not limited to EM excursion, deviation, CAPA and out-of-specification reports.

· Assigns completion of investigations to other technical writers or EM analysts as needed.

· Develops technically justified recommendations and resolutions to investigation conclusions and ensures timely completion of reports, corrective actions and associated activities.

· Assigns action items to other departments for CAPA and tracks completion as needed.

· Supports cross-functional efforts for investigations owned by other departments.

· Represents the Microbiology Department in both internal and external meetings and liaises with clients to close investigations and ensure timely batch release.

· Participates in internal and client audits as needed.

· Reviews and approves lot specific Environmental Monitoring (EM) data for accuracy and initiates corrective action where required.

· Trains team members on technical writing skills.

· Writes department protocols and reports.

· Prepares Standard Operating Procedures (SOPs) for approval and initiates revisions to current SOPs.

· Generates and evaluates department metrics/data for trends for management review, and presents departmental metrics at Quality Council.

· Supports Contamination Control efforts by generating metrics and assessing EM data for relevant topics to discuss with cross-functional team.

· Reviews data obtained for compliance to specifications and reports abnormalities to supervisor.

· Keeps abreast of basic regulatory requirements that affect the department and suggest process and compliance changes as needed.

· Regular and reliable attendance on a full time basis [or in accordance with posted schedule].

· Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

· Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

Requirements :

· Bachelor’s degree in Life Sciences discipline or equivalent.

· Minimum of 6 years of experience in Microbiology.

· Previous experience with technical writing and performing investigations.

· Significant knowledge of GMPs, environmental monitoring (EM) and contamination control, microbiological methods, and aseptic processing.

· Proficiency with MODA, CPMS, and other GMP software preferred.

· Ability to work independently, within prescribed guidelines, or as a team member.

· Knowledge of regulatory requirements.

· Excellent written and verbal communication skills.

· Proficiency with Microsoft Office applications.

The anticipated hourly range for candidates who will work in California is $27.44 - $38.41.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will pass a background check and drug screen as a condition of employment.

We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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