Manufacturing Investigator I

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

About the role

Under direct supervision, this position may investigate, author, coordinate, and revise deviations, corrective and preventative actions, complaints, and other cGMP documents such as Master Production Batch Records. The Manufacturing Investigator I supports simple write-ups and the resolution of issues or risks related to Manufacturing. This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation.

Responsibilities

• Initiates and supports the timely completion of investigations and resolution of issues related to Operations under direct supervision.
• May support cross-functional teams.
• Authors and revises batch records, deviations, complaints, and other technical documentation.
• Manages specific components of large-scale deviations.
• Tracks and trends relevant documentation and data as specified.
• Maintains a GLP/cGMP environment and follows SOPs.
• Adjusts responsibilities and activities to meet client and internal expectations.
• Follows up on open documents to ensure timely close out of batch record revisions and investigations.
• Provides support for internal and client audits as needed.
• Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
• Exhibits professional behavior with both internal and external business associates that reflects positively on the company and aligns with company policies and practices.
• Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
• Fosters a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].

Requirements

• Associate’s or bachelor’s degree preferred. High School diploma or equivalent required.
• 1-2 years of relevant experience in manufacturing.
• Minimum of 1 year of relevant experience in cGMP environment preferred.
• Previous investigations experience preferred.
• Familiarity with relevant technical documentation (SOPs, preventative actions, deviations, etc.) preferred.
• Detail oriented with strong English writing skills.
• Strong verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Highly proficient with Microsoft Office applications.

Pay

The hiring rate for this position is $19.54 - $21.98 per hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.

Benefits

• Paid time off
• Health insurance coverage (including dental and vision)
• Flexible spending account
• 401(k) plan