Quality Control Senior Associate

Job Summary: QC CAS - Sr Associate

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing of Commercial, Stability, Utilities, raw materials and Validation.

• 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

• Strives to complete activities right first time

Extended hours and weekend work flexibility may be necessary as required.

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Specific Job Duties:

• Plan and perform analyses with great 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.

• Review protocols and perform assay validation and equipment qualification/ verifications when required.

• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

• May contribute to regulatory filings.

• May conduct lab investigations as necessary.

• Evaluate lab practices for compliance on a continuous basis.

• Approve lab results.

• May interact with outside resources.

• LIMS data coordination of commercial and import testing on site where applicable

• May represent the department/organization on various teams.

• May train others.

Primary Knowledge, Skills, Competencies and Relevant Experience

Knowledge:

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

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

Skills:

• Communication skills (verbal and written) at all levels

• 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

• Investigation 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:

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

•  Works under minimal direction Work is guided by objectives of the department or assignment

• Follows procedures

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

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

• Recognizes and escalates problems

• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues

• Auditing documentation and operation process

• Demonstrated ability to interact with regulatory agencies

Relevant experience:

• Bachelor’s degree in a Science related field is required. 

• 4+ 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 cGMP manufacturing and testing of pharmaceutical products.