Quality Assurance Associate (3rd shift)

Lead Candidate; Fishers (IN); On-site; USD 50,000 - 65,000; Full time

Benefits offered by this job

Paid time off

401(k) plan with company match

Onsite wellness facility

Job summary

A leading pharmaceutical company in Fishers, Indiana is seeking a Quality Assurance Associate for the 3rd shift. The role involves ensuring compliance with regulations and quality systems, and requires a Bachelor's Degree in a related field along with a minimum of 2 years of experience in a GMP manufacturing environment. Benefits include paid time off, health plans, and employee engagement activities.

Qualifications

• Minimum of 2 years of experience in Quality within a GMP environment.
• Moderate knowledge of quality systems like CAPA.
• Ability to work third shift (11:00pm-7:30am).

Responsibilities

• Maintain Quality Assurance presence on the manufacturing floor.
• Review and approve documentation for quality approval.
• Collaborate with operations to resolve deviations.

Skills

GMP Manufacturing experience

Regulatory knowledge

Attention to detail

Education

Bachelor’s Degree in Science

Job description

Talent Partner | Fuelling growth for CDMOs, CROs and Pharma Services

Overview

Quality Assurance Associate (3rd Shift) – Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards and organizations SOPs. They will also support in championing and developing the organization’s Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps.

Responsibilities

• Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
• Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc.
• Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.
• Support other QA personnel with batch record reviews, material release, etc.
• Prioritize and coordinate his/her time in balancing production timelines with product quality assurances.
• Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.

Qualifications

• This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support, dependent on operations’ needs.
• Bachelor’s Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
• Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment.
• Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..

Why INCOG / Benefits

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Details

• Seniority level: Associate
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing