Apex Systems QA Compliance Specialist - GMP manufacturing operations in Framingham, Massachusetts

QA Compliance Specialist - GMP manufacturing operations in Framingham, MA at APEX Systems

Date Posted: 1/5/2019

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Job Snapshot

  • Employee Type:

Contractor

  • Location:

Framingham, MA

  • Job Type:

Other

  • Experience:

Not Specified

  • Date Posted:

1/5/2019

Job Description Job #: 921024

Responsibilities:

  • Perform batch record review

  • Perform log book review

  • Provide on the floor support to the operations department

  • Perform media and buffer review

  • Support internal audit preparations and conduct walkthrough inspections

  • Revise procedures and SOPs

  • Initiate deviations upon identification of non-conformance

  • Review CV related documentation against specifications

  • Assemble intermediate Bulk release summary

  • Maintain control of key log

  • Provide off-hour support for batch record and log book assistance as needed

Qualifications:

  • Bachelor’s degree or higher in a Scientific discipline.

  • Bachelor's Degree with 3+ years of experience in Quality or cGMP operations OR Associate's Degree with 5+ years of experience in Quality or cGMP operations

  • Experience in bio-pharmaceutical industry preferred

  • Experience in Quality Systems desired

  • Effective time management, attention to detail, organizational skills, teamwork, and collaboration abilities

  • Ability to gown and gain entry to manufacturing areas

  • Ability to work a 12-hour rotating shift and every other weekend, including some holidays

  • Ability to lift 10 lbs as needed

*For immediate consideration, please email your updated resume to Ljohnson@apexlifesciences.com with 'QA Compliance Specialist MA' in the subject line.

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