PCI Pharma Services · 7 hours ago
QA Specialist II - Operations
Bedford, NH, USA
Full-time
Onsite
Mid Level
3+ years expPCI Pharma Services is a company focused on life-changing therapies and their global impact. They are seeking a QA Specialist II to provide quality assurance support for manufacturing and visual inspection activities in a GMP facility, ensuring compliance with regulatory standards and quality improvements.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing
Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems
Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures. May include management from groups such as Operations, Facilities, Quality, and Materials Management
Batch record review for adherence to internal procedures and Good Documentation Practices
Support the evaluation and disposition of intermediates, finish bulk drug substance and drug product
Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient
QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
Co-ownership of nonconforming material investigations
Review of Quality Control environmental and utility monitoring data and test results
Review and approval of work orders impacting manufacturing facilities and utilities
Root cause analysis using methodologies, such as: fishbone, 5 whys, etc
Advise and coach internal customers on proper documentation of tasks
Initiation of Quality Systems (deviations, CAPA, Nonconformances)
Perform Acceptable Quality Limit (AQL) visual inspection of final drug product
Support Visual Inspection, packaging, and labeling operations
Create, review, and approve final product labels
Perform inspection of final product retains
SOP revision as it pertains to process improvements
Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary
Support internal, client, and regulatory audits and inspections
Obtain Qualified Trainer status on department specific training tasks; train new and less experienced team members
Recommend and support improvement ideas and projects
Interact with clients during client visits
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
Qualification
Required
Bachelor's degree in a relevant scientific field
Minimum 3 years' experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience
ASQ certification is a plus
Exposure to RCA, technical writing, and working with quality related investigations
Preferred
Exposure to lean operation excellence highly desirable
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase