QC Analyst I - Sample Handler

Responsibilities and Job Duties:

• Performs inspection, sampling and testing of incoming raw materials according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents, per schedule and within established turn-around times.
• Collaborates with Materials Management to receive and prepare shipments of raw material samples, lot release samples and stability samples for testing performed by contract laboratories.
• Follows established procedures and performs tasks in accordance with cGMP requirements.
• Prepares composite samples and aliquots using aseptic technique in ISO 5 and ISO 8 areas and in biological safety cabinets.
• May perform routine analytical testing including more complex methods such as cell culture and growth promotion as well as basic methods such as concentration by UV absorbance, pH, conductivity, appearance and osmolality, draeger tube gas testing, Raman IR, and environmental monitoring, in accordance with all protocols and procedures.
• Performs physical inspections of stored materials and maintains accurate tracing / tracking of Quality Control sample and retain inventory.
• Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP. Compiles and reviews data ensuring data integrity and adherence to SOPs. Ensures data storage and archiving are performed per established procedures.
• Ensures that instruments and equipment used in inspection, sampling and testing are kept in a qualified and calibrated state and raises any concerns about equipment to supervisor for resolution.
• Maintains the sampling room at constant state of cleanliness, compliance and inspection readiness and ensures that sampling room and sample packaging inventory is stocked with required cleaning solutions, sample containers, labels, etc. Orders materials via SAP.
• Reports discrepancies and nonconforming materials to management and supports subsequent investigations and other Quality event records (e.g., Deviations and CAPAs) in electronic document management system (MasterControl), and coordinates with appropriate departments when there are issues/concerns.
• Prepares general lab solutions and buffers as needed and monitors expiration of these solutions and buffers.
• Performs other duties as assigned.

Qualifications:

Education, Experience, & Credentials

• High School Diploma and minimum of two years directly related experience; or
• Associate's Degree and minimum of one year directly related experience; or
• Bachelor's Degree in a scientific discipline
• Experience in one or more of the following areas required: Aseptic technique, cell culture, ISO 5 sampling, ISO 8 sampling, GMP clean experience, Quality Control, or GMP testing.

Knowledge, Skills and Abilities

• Working knowledge of good laboratory practices
• Needs to be able to follow directions that are outlined in SOPs and other quality guidelines
• Ability to organize daily activities to meet internal customer needs in a fast-paced environment
• Knowledge of basic chemistry concepts
• Ability to understand when he/she should seek advice and guidance
• Data entry skills (LIMS experience a plus)
• Microsoft Office skills
• Ability to work in a team environment in a cooperative and respectful manner
• Ability to rotate and/or fill in at Rockville, MD, sites
• Ability to stand for periods of time when performing tasks on the floor
• Ability to work a varied schedule including off shift and weekends
• Ability to lift up to 50 pounds

Supervisory Responsibilities

• None

Additional Information

The annual equivalent of pay for the Manufacturing Associate I position ranges from $50,250 - $83,750. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.