QMS Investigator III
PCI Pharma Services
Summary
The position investigates and writes out-of-specifications, deviations, preventive actions, change controls, and other related cGMP documents under minimal supervision. The role supports semi-complex investigations and resolution of issues/potential problems related to Operations/Production. The position writes and edits standard operating procedures (SOPs), change controls, and other related CGMP documents. This position works cross-functionally to coordinate the review, approval and revision of procedures, documents, specifications and forms. The Investigator will work with multiple departments and CGMP disciplines, such as Manufacturing operations, Quality Control, Microbiology, Facilities, and Quality Assurance.
Job description
Essential Duties and Responsibilities
- Initiates and/or supports semi-complex investigations and resolution of issues and/or potential problems related to QMS and/or Operations/Production.
- Coordinates and supports interdisciplinary working teams with recommendations, advice, and action plans for semi-complex investigations, change controls, gap analyses, and risk assessments.
- Authors and revises change controls and other technical documentation.
- Manages specific components of large-scale deviations.
- Tracks and trends 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 close out of investigations to enable product release in a timely manner.
- Provides support to internal, client, and regulatory audits as needed.
- Participates in limited discussions with clients regarding investigations.
- 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.
- 5-7+ years of relevant experience in a CGMP environment, Manufacturing preferred.
- Has strong understanding of equipment, systems and technologies that enable issues to be translated using accurate documentation.
- Previous experience with investigations is required.
- Previous experience writing technical documentation (deviations, corrective and preventative actions, SOPs, etc.) is required.
- Relevant aseptic processing and compliance experience required.
- Must have a solution-based attitude.
- Aseptic gowning experience and mechanical aptitude are preferred.
- Strong listening and interpretive skills to successfully translate events into clearly written documents.
- Detail-oriented with very strong English writing skills.
- Strong verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Must be highly proficient with Microsoft Word and Excel.
Please Note: This is an evergreen posting intended to build a pipeline of qualified candidates for current and future opportunities. Candidates may be contacted as business needs arise.
Requirements
- High School diploma or equivalent required
- Bachelor's degree in Life Sciences or related field preferred
- 5-7+ years of relevant experience in a CGMP environment
- Previous experience with investigations required
- Previous experience writing technical documentation (deviations, CAPAs, SOPs) required
- Relevant aseptic processing and compliance experience required
- Strong understanding of equipment, systems and technologies
- Must have a solution-based attitude
- Aseptic gowning experience and mechanical aptitude preferred
- Strong listening and interpretive skills
- Detail-oriented with very strong English writing skills
- Strong verbal communication skills
- Ability to work independently or as a team member
- Highly proficient with Microsoft Word and Excel
Benefits
- Paid time off
- Health insurance
- Dental insurance
- Vision insurance
- Flexible spending account
- 401(k) plan
- 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.