Job Summary

The Quality Assurance Complaints Specialist ensures manufacturing procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The position supports operational needs and activities in order to successfully achieve quality goals and complaints metrics.

Core Responsibilities

• Handles product complaints received from customer service department.
• Initiates, process and send notifications as required by applicable Standard Operating Procedures (SOPs).
• Interacts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint.
• Evaluate complaints for regulatory reportability and create and submit reports that comply with applicable regulations.
• Writes, investigates and ensures timely submission of complaints investigation.
• Reviews and approves complaint investigation submitted by other team members.
• Collaborates with other departments to ensure technical issues are being addressed and investigations are conducted thoroughly.
• Initiates applicable Corrective Action/Preventative Action (CAPA) plans.
• Accurately maintain product complaint logs (softcopy and hardcopy) through internal database tracking system and complete all filing and closing procedures as required by applicable Standard Operating Procedures (SOPs)

• Responsible for ensuring that paperwork is complete for each complaint folders.
• Perform other duties and assume responsibilities as appropriate or assigned.

Qualifications & Requirements

• Bachelor’s degree required, preferably life sciences
• 2+ years of experience in pharmacy operation or experience in cGMP environment
• Must be able to facilitate collaboration, while knowing when to move to end analysis and recommend decisions
• Strong written, verbal and presentation communication skills
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) required
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards

Position Type

• On-Site

Travel

• None

Job Summary

The QA Compliance Intern will provide foundational administrative and operational support to the Quality Department. This role is designed to offer a student or recent graduate hands-on experience in oversight of external manufacturing operations and Contract Manufacturing Organization (CMO) partnerships. As an intern, you will assist in ensuring compliance with international regulatory requirements and industry standards and support the internal quality team with various tasks and projects.

Core Responsibilities

• Assist in the initiation and administrative tracking of incoming inquiries, including Product Quality Complaints (PQCs), Adverse Events (AEs), and Medical Inquiries (MIs).
• Support the Quality Team in maintaining seamless communication between internal departments (Supply Chain, Pharmacovigilance, Regulatory Affairs) and external manufacturing partners.
• Learn to support the initiation of investigations, CAPAs (Corrective and Preventive Actions), change controls, and validation documentation within a Good Manufacturing Practice (GMP) environment.
•  Monitor the general QA mailbox, ensuring inquiries are routed to the appropriate stakeholders in a timely manner.
• Assist in the maintenance and implementation of internal policies, procedures, and training programs.
• Contribute to the organization of files and documentation required for internal and external audits.
•  Provide general project management support for the Quality Department, including data entry into Excel and drafting correspondence.

Qualifications & Requirements

• Currently enrolled in or a recent graduate of a BA/BS program in Life Sciences, Chemistry, Pharmacy, or a related field.
• Previous internship or coursework related to Quality Assurance, Quality Control, or Regulatory Compliance is a plus but not required.
• Excellent verbal and written communication skills with a focus on professional email etiquette.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook) is required.
• High attention to detail and the ability to manage multiple assignments simultaneously while meeting deadlines.
• Ability to ask compelling questions and a desire to understand
• Ability to work both autonomously and collaboratively in a fast-paced environment.
• Basic knowledge of CAPAs, Deviation investigations, Change Controls, and Supplier Qualification Program.

Position Type 

• Remote

Travel

• (5% travel)

Job Summary

The Environmental Monitoring Technician will perform environmental monitoring and routine microbiology testing within a GMP drug manufacturing organization.

Core Responsibilities

• Perform routine environmental monitoring (EM: non-viable particulates, air viable, surface, and personnel) in cleanroom environments.
• Maintained the microbiology laboratory, including monitoring equipment function, for example, temperatures of QC incubators. 
• Perform reads on media fill samples.
• Collect Water for Injection (WFI) and pre-treatment water samples throughout the manufacturing facility and perform microbially, TOC, and conductivity testing of samples.
• Incubate and read EM plates and document results on relevant forms.
• Send the plates for Microbial ID to a third-party lab. 
• Trend data for EM and water samples and assist with preparing quarterly EM reports.
• Manage routine monitoring of other facility utilities, including compressed air.
• Manage sample chain of custody for raw material, finished goods, and sterile components with third-party laboratories. 
• Managers retain a sample chain of custody.
• Responsible for initiating, investigating, and writing deviation.
• Manage gown qualification program.
• Performs other Quality duties as required, including the execution of the sample management program. 

Qualifications & Requirements

• Prefer a Bachelor's degree (B.S.) in Microbiology or Biology and 3-5 years of sterile pharmaceutical manufacturing plant experience. 
• Ability to apply knowledge of good manufacturing practices and good laboratory practices daily.
• Understanding and ability to perform aseptic and relevant microbiological techniques.
• Ability to follow gowning practices for cleanroom environments.
• Must be a team player.
• Monitors own work to ensure quality.
• Completes work promptly.
• Adapts to changes in the work environment.
• Willing to work additional hours when required and works on weekends when necessary to reach goals.
• Completes tasks on time or notifies the appropriate person with an alternate plan.

The hours for this role are 3pm to 1:30am

Job Summary

This position will ensure that the operations follow the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The QA Manufacturing Specialist will provide Quality oversight of the Manufacturing and Production areas, including compounding, filling, inspecting, and labeling/packaging. Management includes the periodic review of in-process activities such as cleaning, weighing, aseptic filling, material status verification, compounding, batch record documentation accuracy, logbook documentation accuracy, and room/line clearances. 

Core Responsibilities

• Provides Quality oversight of Production activities, including compounding, aseptic filling, inspection, and labeling/packaging on the floor.
• Provides Quality oversight of cleaning activities to ensure compliance with cleaning requirements. 
• Product label review and approval. 
• Oversight and confirmation compliance with Filling Operations, including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms, and batch records. 
• Verification of proper gowning by all personnel in all areas of Production.
• Generation of deviations, issuance of CAPAs, and Change Controls in response to observations.
• Oversee all Quality aspects on the floor.
• Participate in regulatory audits if required. 
• Performs or assists process owners with the root cause analysis.
• Responsible for generating deviations and change controls when required. 
• Performs duties following established company procedures and policies; performs other duties as assigned.

Qualifications & Requirements

• 3-5 years of progressive experience in cGMP quality operations and FDA regulations, a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment, or equivalent technical experience.

• High school degree
• BS in the Scientific field preferred

• Three-plus years of experience with aseptic drug product manufacturing is required.
• A fundamental, working knowledge of safety, quality systems, and quality assurance concepts are required, including the application of current Good Manufacturing Practices and Good Documentation Practices.
• Strong familiarity with manufacturing processes, operations, automation, and equipment/facilities.
• Ability to complete tasks with little direction or need for supervisory follow-up.
• Strong written, verbal, and presentation communication skills.
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and others must be able to learn additional software as required).
• Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
• Work schedule flexibility.