Quality Analyst - Hiring Now

Position Summary:

The Quality Analyst I performing quality control (QC) inspection and disposition of materials and products according to specifications. This role will perform QC inspection using measuring instruments (when applicable) and inspection methods. The role ensures any non-conforming materials or products that are identified are managed according to the Quality System. The Quality Analyst is responsible for following all policies and procedures to ensure compliance with applicable with FDA, state OSHA and ISO regs and standards. Employees within this role will performs a variety of tasks under limited supervision.

This is a 6 month contract with the potential to be extended, based on project demand.

Primary Responsibilities:

• Performs reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinates and tracks CAPA, NCR and Deviation records, ensuring tasks are completed on time.
• Coordinates and tracks the site environmental monitoring (EM) testing program.
• Assists teams in coordination of problem solving and root cause analysis for associated quality events.
• Ensures the development, review, and release of quarterly EM trending reports; Assures significant trends are immediately brought to management attention.
• Provides input based on knowledge and experience with batch release requirements.
• Provides QMS Operations related support to all CGMP departments.
• Performs Quality Control activities at processing or distribution sites.
• The Quality Analyst will be responsible for incoming material inspections, in-process inspections and finished product inspections.
• Products include Medical Devices, sterile processed Human Tissue-Based Products, unprocessed human tissue, components supplies and labeling materials.
• The Quality Analyst will maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
• Provides support related to gowning qualification and training.
• Ensures timely issuance, review, and approval of Microbiology and EM testing results.
• Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
• Assists in the review and approval of equipment qualifications.
• Assists in the review of Calibration and Preventative Maintenance reviews.
• Assists in hosing of onsite regulatory audits and inspections.

Educational Requirements / Qualifications:

• Bachelor’s Degree in a Life Science discipline and/or in a related field
• Bachelor’s degree in engineering preferred.
• Minimum of 0-2 years of relevant industry experience within a Medical Device, Pharmaceutical, or Tissue commercial organization.

Specific Qualifications Needed to be successful in the role:

• Familiarity with ANSI/ASQ Z1.4-2003, c=0 and AQL methodologies preferred
• Experience in an FDA-regulated environment, particularly medical device, human tissue or pharmaceutical manufacturing preferred.
• Experience with Microsoft Excel
• Experience writing Standard Operating Procedures and Work Instructions
• Experience with Quality System elements for CAPA, Non-Conforming Reports (NCRs) and Deviations.

Physical Requirements: The work is sedentary work which requires exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Additionally, the work requires the following: mental acuity, visual acuity, walking, repetitive motion, speaking, talking, hearing, and typing.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.