Technical Writer - change controls in Lansdale, PA at Apex Life Sciences

Date Posted: 10/2/2018

Job Snapshot

Job Description


Responsibilities:

  • Process Change Controls to completion.
  • Update and author change control documents. These Change Control documents include the Standards used for testing to release products and the Protocols used to qualify the Standards.
  • Work with initiators to update the change controls including check on the correct Materials and Impacted Products for the change control.
  • Work with Quality and Regulatory personnel to complete them.
  • Issue the Reagent Table and the History bi-monthly.
  • Maintain and update spreadsheets to track the Reagent Table.
  • Support new and in-line vaccine programs
  • Provide analytical assay support for in-line product improvement studies. Provide technical support for new and in-line products
  • Participate in departmental and cross functional project teams
  • Document work as required for GMP compliance

Qualifications:

  • BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry
  • Technical/Scientific report writing a must
  • Ability to perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Proven ability to work independently and as part of a team, self-motivated, adaptable, and a positive attitude.
  • Strong scientific, computer, organizational, and documentation skills, attention to detail.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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