QMS Investigator II

Summary

QMS Investigator II

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity andInclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

This position investigates and writes out-of-specifications, deviations, corrective and preventive actions, change controls, and other related cGMP documents under moderate supervision. The QMS Investigator II supports moderately complex investigations and resolution of issues / potential problems related to Operations/Productions.

The position writes and edits standard operating procedures (SOPs), change controls, and other related CGMP documents. In addition, the role may 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.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.

• Initiates and/or supports moderately complex investigations and resolution of issues / potential problems related to QMS and/or Operations/Production.
• Coordinates and supports interdisciplinary working teams with recommendations, advice, and action plans for moderately complex investigations, change controls, gap analyses, and risk assessments.
• Authors and revises change controls and other technical documentation.
• Manages specific components of moderately large-scale deviations.
• Tracks and trends documentation and data as specified.
• Maintains a GLP/CGMP environment and follows Standard Operating Procedures (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 for internal, client, and regulatory audits as needed.
• 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.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

• constantly required to sit, and to reach to use computers and other office equipment
• occasionally stand for extended periods of time, up to four (4) hours/time.
• occasionally required to lift up to 10 pounds
• frequently required to view objects at close and distant ranges with hand and eye coordination
• constantly required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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.
• 3-5 years of relevant experience in a CGMP environment, Manufacturing preferred.
• Has an established understanding of equipment, systems and technologies that enable issues to be translated to create accurate documentation.
• Previous experience with investigations is preferred.
• Previous experience writing technical documentation (deviations, corrective and preventative actions, SOPs, etc.) preferred.
• Emphasis on aseptic processing and compliance experience preferred.
• Must have a solution-based attitude. Aseptic gowning experience and mechanical aptitude are a plus.
• Strong listening and interpretive skills to successfully translate events into clearly written documents.
• Detail oriented with 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.

Job Description

QMS Investigator II

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity andInclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

This position investigates and writes out-of-specifications, deviations, corrective and preventive actions, change controls, and other related cGMP documents under moderate supervision. The QMS Investigator II supports moderately complex investigations and resolution of issues / potential problems related to Operations/Productions.

The position writes and edits standard operating procedures (SOPs), change controls, and other related CGMP documents. In addition, the role may 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.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.

• Initiates and/or supports moderately complex investigations and resolution of issues / potential problems related to QMS and/or Operations/Production.
• Coordinates and supports interdisciplinary working teams with recommendations, advice, and action plans for moderately complex investigations, change controls, gap analyses, and risk assessments.
• Authors and revises change controls and other technical documentation.
• Manages specific components of moderately large-scale deviations.
• Tracks and trends documentation and data as specified.
• Maintains a GLP/CGMP environment and follows Standard Operating Procedures (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 for internal, client, and regulatory audits as needed.
• 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.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

• constantly required to sit, and to reach to use computers and other office equipment
• occasionally stand for extended periods of time, up to four (4) hours/time.
• occasionally required to lift up to 10 pounds
• frequently required to view objects at close and distant ranges with hand and eye coordination
• constantly required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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.
• 3-5 years of relevant experience in a CGMP environment, Manufacturing preferred.
• Has an established understanding of equipment, systems and technologies that enable issues to be translated to create accurate documentation.
• Previous experience with investigations is preferred.
• Previous experience writing technical documentation (deviations, corrective and preventative actions, SOPs, etc.) preferred.
• Emphasis on aseptic processing and compliance experience preferred.
• Must have a solution-based attitude. Aseptic gowning experience and mechanical aptitude are a plus.
• Strong listening and interpretive skills to successfully translate events into clearly written documents.
• Detail oriented with 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.