Job Details

ID #15614937
State California
City Hayward
Job type Contract
Salary USD $39 - $42 39 - 42
Source Sunrise Systems, Inc.
Showed 2021-06-19
Date 2021-06-04
Deadline 2021-08-03
Category Et cetera
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Technical Writer III (Pharmaceutical Industry)

California, Hayward, 94545 Hayward USA

Vacancy expired!

Sunrise System Inc. is currently looking for

Technical Writer III in

Hayward, CA with one of our top client.

Job Title: Technical Writer III

Job Id: 21-06905

Location: Hayward, CA 94545

Duration: 6 months

Position

Type: Hourly contract Position (W2 only)

Description
  • Technical Writer Level III offers precise and accurate writing, editing, and planning skills and brings a greater leadership role within the engineering group at Lonza. This position provides support within the department and also throughout the business, offering keen insight to process-related knowledge and manufacturing as related to data integrity, computer system validation and technical engineering SOPs.
  • Technical Writer Level III has a deep understanding of how their work directly affects ease of operations within the building, patient safety, drug quality, and business reputation.

Key Accountabilities and Duties:
  • Edit and create documents following predefined Lonza templates/standards: Review and template documents with accurate, clear, and explicit description and justifications while developing proficiency in both data integrity and computer system validation principles.
  • Creates new cGMP documents with minimal assistance.
  • Manage document DMS workflow (Review, response to comments and approval): Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the aid of document owners, SMEs and QA.
  • Able to author any CAPAs related to data integrity & commercialization events.
  • Review and maintain document schedules/campaigns: Notify associated departments of deadlines and keep documents within their scheduled timeframe with minimal oversight.
  • Become proficient in both data integrity and computer system validation processes and procedures.
  • Support and implement continuous improvement initiatives.

Minimum Required Qualifications/Skills:
  • Strong written and oral communication skills
  • Detail oriented
  • Advanced proficiency in MS Suite, particularly Word, Excel
  • Word Processing experience
  • Able to navigate in an electronic quality management system (TrackWise) and major content management systems (DMS).
  • Highly organized
  • Proofreading/editing

Preferred Experience:
  • Prior experience in a GMP regulated laboratory / manufacturing environment
  • Understanding of GMP and data integrity (ALCOA+)

Contact

Rahul

Direct|Email:

Or

Michael Peng

Direct|

Vacancy expired!

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