Sr Associate QC - Microbiology

Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.

Specific Job Duties

Perform analytical testing as a main priority with efficiency and accuracy

• Demonstrate technical flexibility by working across diverse areas within the lab.

• 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 assist in equipment qualification/verification.

• 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 contribute to regulatory filings.

• May represent the department/organization on various teams.

• May interact with outside resources.

Basic Qualifications

Bachelors degree in a science discipline

• Biopharmaceutical QC experience in a microbiology lab

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Preferred Experience/Knowledge

• Experience in a wide variety of microbiological techniques, including but not limited to Bioburden (In-process product & Utility samples), Endotoxin (Kinetic and Gel clot), Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Growth Promotion, Media prep, Water Sampling.

• Understanding and application of principles, concepts, theories and standards of GMP QC Microbiology laboratories. Deepens technical knowledge through exposure and continuous learning

• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.

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

• Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope

• Ensures compliance within regulatory environment

• Develops solutions to technical problems of moderate complexity

• Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues

• Interprets generally defined practices and methods

• 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

Competencies:

• Background in microbiology and aseptic manufacturing

• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage

• Flexibility – the role often encounters changing priorities (also required to work weekend on call – Rota system)

• Follows procedures and ALCOA principles

• Demonstrated ability to work independently and deliver right first time results

• Works under minimal direction, recognizes and escalates problems

• Work is guided by objectives of the department or assignment

• Refers to technical standards, principles, theories and precedents as needed

• May set project timeframes and priorities based on project objectives and ongoing assignments.