QMS Investigator III
About The Position
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.
Requirements
- High School diploma or equivalent required.
- 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.
- 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.
Nice To Haves
- Bachelor's degree in Life Sciences or a related field preferred, or equivalent combination of education and/or relevant work experience will be considered.
- Aseptic gowning experience and mechanical aptitude are preferred.
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 [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.
- 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.
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- a flexible spending account
- a 401(k) plan
- annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
