Quality Analyst

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Job description

Position is 100% Onsite.

Required Skills:

• Bachelor's degree in Chemistry or related field from an accredited college or university and at least 3 years of quality engineering or related QA experience in a cGMP manufacturing environment with at least 7 years in pharmaceutical manufacturing or equivalent.
• Experience in Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging environment .
• Experience in change management process .
• Experience of Root Cause Analysis (5 Whys, 6M's, Is/Is Not, FMEA, etc.) in support of writing, reviewing, and approving investigations to determine root cause and adequate corrective/preventive actions to prevent recurrence.
• Experience in Auditing techniques in a cGMP facility.
• Experience and mastery in technical writing for investigations, protocols, and reports in English language.
• Knowledge of Lean / 5s application .
• Strong understanding of GLP .
• Ability to transfer compliance knowledge to team members and partners .

Project Description:

• Quality Analyst professional at an aseptic, sterile vial fill and finish manufacturing and packaging facility responsible for quality review and approval of protocols, reports, change controls, investigations, CAPAs and other compliance activities (i.e., APRs, stability reports, tech transfers) related to the plant operations.
• The incumbent will be a key team member of the QA team responsible for QA oversight of the plant operations, including but not limited to review and approval of investigations, change controls, and CAPAs.
• Under limited guidance, supports and ensures the compliance operations in Operations.
• Partners with other departments to support problem resolution and escalation, as needed.
• Executes and interprets key metrics and trend charts using data and/or statistical analysis in support of Annual Product Review and Quality Metrics.
• Drives quality risk assessment as well as effectiveness checks as part of Change Control and CAPA processes.
• Demonstrates effective leadership and teamwork to junior and senior level Quality personnel.
• Complies with all company policies and procedures, including safety rules and regulations, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging operations.
• Performs other related duties as assigned.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jim:

ALPHA'S REQUIREMENT #21-04089
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#LI-JP1 - provided by Dice

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