Investigations & Control Specialist

INV Writer

Must-haves

• University/Bachelor's Degree or higher in a technical discipline
• 3-5 years related experience in a pharmaceutical and/or consumer healthcare manufacturing facility
• Experience with 21CFR 210 and 211(FDA Code of Federal Regulations) and GMP
• Quality experience - INV/CAPA processes (Investigation and Corrective and Preventive Action) and performing quality investigations
• Root cause analysis
• Process engineering or operational experience
• Strong technical writing skills (process documentation, quality investigations, etc.)

Bonuses

• CQE and/or CQA certification
• Lean/Six Sigma knowledge

Day-to-Day

• Our large Consumer Manufacturing Client is seeking an Investigations & Control Specialist in Lititz, PA.
• The organization manufactures oral hygiene and personal care products, and this individual will be assigned to the Oral Care business unit.
• Currently, the Process Engineers in each area are handing the majority of quality investigations, and the goal of this position is to take the quality work off their plate so they can focus on continuous improvements.
• We are looking for an individual with a manufacturing industry background and who is familiar with FDA Code of Federal Regulations (21CFR 210 and 211 specifically) and GMP standards.
• In addition, they should have experience performing root cause analysis for quality investigations, process or operational expertise, and great technical writing skills.
• This individual will be brought on as a long-term contractor (12-24 months possible extensions) and with solid performance, will be the first to be considered for relevant permanent positions that open up.
• This is an exciting opportunity to grow with an excellent company!

Job Type: Contract

Salary: $45.00 - $46.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Lititz, PA 17543: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA Code of Federal Regulations: 2 years (Required)
• Quality and CAPA: 3 years (Required)
• pharmaceutical or consumer healthcare: 1 year (Required)

Work Location: One location