Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a QC Technical Data Reviewer.

ABOUT INCLUSIVELY:

Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD). Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.

The annual base salary for this position ranges from $75,700.00 to $126,300.00.

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
• Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
• Perform tasks associated with maintaining Current Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
• Support preparation of media, receipt, storage and handling of Bio ball cultures, and investigations related to microbiology.
• Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.
• Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
• Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
• Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects
• Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report.
• Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.
• Train junior colleagues and may develop training plans and/or oversee training activities for groups.

Qualifications

Must-Have

• High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience
• Technical Skills Experience in MLT method validation and testing
• Experience in microbiological testing of water
• Understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
• Detail oriented with Quality systems knowledge
• Knowledge of research unit clinical and analytical Laboratory environment
• Excellent effective written and verbal communication and interpersonal skills
• Ability to work in a team environment

Nice-to-Have

• Knowledge of computer system hardware, infrastructure and networks

Physical / Mental requirements

• Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
• Intellectual capability to perform complex mathematical problems and perform complex data analysis.

Non Standard work schedule, travel or environment requirements

• Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.
• Limited travel for the position; no more than 10% traveling.

Job Type: Full-time

Pay: $75,700.00 – $126,300.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Parental leave
• Vision insurance

Experience level:

• 1 year
• 3 years
• 6 years
• 8 years

Schedule:

• Day shift
• Monday to Friday
• Night shift
• Weekends as needed

Work setting:

• In-person

Work Location: In person