Manufacturing Investigator I (Batch Record Author)
About The Position
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. 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. SUMMARY: 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.
Requirements
- Associate’s or bachelor’s degree preferred. High School diploma or equivalent required.
- 0-2 years of relevant experience in manufacturing.
- 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.
Nice To Haves
- 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.
Responsibilities
- Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations.
- 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.
- Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Benefits
- PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
1-10 employees
