QMS Investigator I
PCI Pharma Services
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 QMS 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.
Job description
Essential Duties and Responsibilities
- Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations/Production. May support cross-functional teams.
- Authors and revises 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/records to ensure timely close out of batch record revisions and investigations.
- Provides support for internal, client, and regulatory 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.
- 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.
- Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.
- Performs other duties as assigned to support departmental and organizational objectives.
Qualifications
- High School diploma or equivalent required. Bachelor's degree in Life Sciences or a related field preferred, or equivalent combination of education and/or relevant work experience will be considered.
- 1-3 years of relevant experience in a CGMP environment, Manufacturing preferred.
- Previous experience with investigations preferred.
- Familiarity with relevant technical documentation (deviations, corrective and preventative actions, SOPs, 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.
Requirements
- High School diploma or equivalent required
- Bachelor's degree in Life Sciences or related field preferred
- 1-3 years of relevant experience in a CGMP environment
- Manufacturing experience preferred
- Previous experience with investigations preferred
- Familiarity with technical documentation (deviations, CAPAs, SOPs) preferred
- Detail-oriented with strong English writing skills
- Strong verbal communication skills
- Ability to work independently or as a team member
- Highly proficient with Microsoft Office applications
Benefits
- Paid Time Off
- Health Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account
- 401(k) Plan
- Annual Performance Bonus
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.