Quality Assurance Specialist I (Swing Shift) *PC 1512

Your Role: 

This position is primarily responsible for the maintenance of quality operations and processes to assure GMP compliance for relevant operations carried out, including activities related to preclinical and clinical supplies and potentially commercial production.

Essential Duties and Responsibilities:

• Implement and maintain quality documentation, including equipment master files, personnel training files, controlled material files, and document control files.
• Update specifications per current USP and EP editions.
• Perform quality reviews for maintenance work orders and instrument calibration assessments. Review equipment cycle and monitoring data to ensure proper operation.
• Perform final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations.
• Perform review of documentation to determine release status. Approve material for release or nonconformance investigation.
• Approve the mechanism for isolating and/or quarantining equipment, facilities, or materials that fail to meet required specifications.
• Quarantine Product pending final release testing.
• Conduct review of batch production records and supporting batch documentation, such as quality control testing data and equipment maintenance and calibration records.
• Assist in investigations, when assigned, to allow for disposition of material and approve return-to-use for quarantine materials or return-to-service orders for equipment and facilities following completion of investigations.
• Perform QA on the floor activities with routine presence in the manufacturing area. 
• Assist in internal compliance and external (supplier) audits as assigned.
• Serve as an internal interface with customers on GMP contract manufacturing projects.
• Able to support 24/7 process operations and shift schedule.

Requirements: 

• Bachelor's Degree; 0-2 years of related experience and/or training; or equivalent combination of education and experience.
• Previous and substantial GMP experience is required, as is prior knowledge of word processing, database management, and record-keeping.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a controlled biological manufacturing cleanroom and microbiology laboratory, using such equipment as particle counters, air samplers, biosafety cabinets, incubators, plate readers and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $73,283- $86,224/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.