Senior Associate QC (24 / 7 Shift)

Senior Associate QC Analytics - Overview:

Under minimal supervision, responsible for one or more of the following activities in QC including HPLC, CE, GELs, analytical testing, characterization, method transfer, sample and data management and equipment maintenance.

• Contributes to team by ensuring the quality of the tasks/services provided by self.
• Contributes to the completion of milestones associated with specific projects or activities within team.

This role will support manufacturing operations, as such work will be as part of a 24/7 shift pattern and flexibility may be necessary.

Specific Job Duties:

• With a high degree of technical flexibility, work across diverse areas within the lab.
• Plan and perform routine analyses with efficiency and accuracy.
• Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Approve lab results.
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on various teams.
• May interact with outside resources.

Knowledge:

• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
• Experience in a wide variety of analytical techniques including but not limited to HPLC, Capillary Electrophoresis, UV and density testing.

Skills:

• Take initiative to identify and drive improvements.
• Excellent verbal and written communication skills.
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Presentation skills.
• Escalate issues professionally and on a timely basis.
• Decision Making skills.
• Teamwork and Coaching others.
• Negotiation and Influence skills.
• Problem solving skills.
  • a. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
  • i. Ensures compliance within regulatory environment
  • ii. Develops solutions to technical problems of moderate complexity
  • iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
  • b. Interprets generally defined practices and methods
  • c. Able to use statistical analysis tools to perform data trending and evaluation
• Project Management and organizational skills, including ability to follow assignments through to completion.

Compentencies:

• Demonstrated ability to work independently and deliver right first-time results
  • a. Works under minimal direction
  • b. Work is guided by objectives of the department or assignment
  • i. Follows procedures
  • ii. Refers to technical standards, principles, theories and precedents as needed
  • iii. May set project timeframes and priorities based on project objectives and ongoing assignments
  • iv. Recognizes and escalates problems
• Demonstrated leadership and communication skills.
• Auditing documentation and operation process.
• Demonstrated ability to interact with regulatory agencies.

Relevant experience:

• Bachelor’s degree in a science discipline.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.

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