Senior Associate Quality Control

Payrate: $37.00 - $39.00/hr.


Summary:
This role requires excellent written communication, grammar, and investigative leadership skills. Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight. They will collaborate with multiple cross-functional teams and should be confident leading meetings and pushing investigations independently through to completion. Experience with Veeva Quality Systems is highly desirable.


Responsibilities:

• Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System.
• Lead investigation teams and help to collect and report metrics for the systems team.
• Assist with review of validation documents to support equipment and computerized system onboarding.
• Author, revise, and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
• Support the startup of a GMP QC laboratory.
• Support routine activities over the weekends and public holidays as required.

Qualifications:

• At least three years of GMP experience.
• The ideal candidate will bring at least 3 years of industry experience within a GMP-regulated biotech or pharmaceutical environment
• Experience as a Deviation Owner with technical writing skills.
• QC Lab experience.

Desired Skills:

• They must demonstrate strong knowledge of quality systems and QC laboratory operations with a proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.
• Experience with Veeva Quality Systems

Pay Transparency: The typical base pay for this role across the U.S. is: $37.00 - $39.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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