Quality Control Senior Associate

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.

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

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

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

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.