The Quality Assurance Senior Technician is responsible for supporting the Quality Assurance team in testing manufactured antibody and protein products, and qualifying incoming critical reagents. This includes the ability to work collaboratively with multiple groups, perform tasks independently, interpret results and troubleshoot. Investigate quality related nonconformances associated with deviations, test failures and test results failing to meet acceptance standards.
Key Responsibilities
Perform all aspects of Quality Assurance assays following SOPs and ISO requirements and review analytical data for accuracy and quality
Ensure test methods are validated or verified as appropriate to the method
Work both independently and collaboratively as part of the Quality Assurance team
Operate and monitor inspection equipment
Calibrate laboratory equipment and notify QA Manager when equipment requires servicing
Assure timely completion and review of testing documentation
Perform testing of products throughout the manufacturing life cycle, including stability samples
Record, review and analyze quality data
Qualify and validate all assays transferred to QA
Ensure the timely and successful resolution of investigations associated with deviations, test failures and test results failing to meet acceptance standards
Perform routine analytical testing for R&D as assigned by QA Management
Work collaboratively with R&D to ensure successful transfer of developed assays to QA and resolve any technical issues that arise during the transfer
Order, review and maintain stocks of standards and other QA reagents as required
Presentation and communication of data and project updates to management
Requirements
Bachelor’s degree in Biochemistry, Chemistry or other Life Science related field
4+ years of bioassay laboratory experience, specifically with ELISA assay qualification and testing
Automated liquid handling experience
Experience in assay development and validation for product analysis using multi-well plate formats
Experience with various techniques and equipment associated with Western Blotting, SDS-PAGE, HPLC and spectroscopy
Proficient in Microsoft Office, including Excel
Preferred Requirements
Experience in supporting stability programs for biotechnology or pharmaceutical products
Experience with statistical software (JMP, SAS, Prism, etc.) for data trending
Working knowledge of ISO 9001:2015 or 13485 standards and Quality Management Systems (QMS) and/or GMP/GLP regulations
Cover Letter REQUIRED - Resumes will not be considered without a cover letter.
Position Summary
Purification of serum proteins to produce the highest quality product possible with high yields in a timely manner through planning, organization, and conscientious attention to accuracy and safety.
This is an entry-level manufacturing position.
Principal Duties and Responsibilities (including, but not limited to):
Perform laboratory activities to company's practices, procedures, and protocols
Precisely conduct tests, analyses, and evaluations to produce the highest yield, highest quality products in a timely manner
Assist in compiling, analyzing, interpreting, and recording results
Maintain accurate records and periodically prepare reports
Communicates with supervisor and other colleagues regarding daily lab activities
Participates in internal meetings as appropriate
Participates in general lab maintenance and cleanliness
Operate, clean, and maintain laboratory equipment and instruments in good working order
Education and Experience Requirements:
BS or BA in Biology or Chemistry, or related degree plus lab experience.
Skills, Knowledge and Abilities Requirements:
Good math skills
Operational knowledge of lab equipment
Detail oriented
Good organizational skills
Good judgment
Ability to work as a team member
Good record keeping skills
Please note: This position is located in West Grove, Southern Chester County, Pennsylvania.
This position is entry level and relocation expenses will not be paid.
Visual Acuity, Hearing, and Speaking: Normal vision, hearing, and clear speech
Environmental Conditions: Normal fluctuations in heat and air conditioning, occasionally enters walk-in unit cooled to approximately 4-8 degrees centigrade. Fumes, dust, noise.
