QA Specialist II - Compliance

PCI Pharma Services•Bedford, NH

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position is responsible for maintaining and adhering to PCI Pharma Services and regulatory compliance requirements for established quality system programs by performing internal audits, hosting client audits, and providing assistance during regulatory agency inspections.

Requirements

Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
High Standard of Report Writing
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

Nice To Haves

Ability to effectively present information to various people as the job requires.
Ability to follow instructions and respond to management direction.
Ability to work independently and/or as part of a team.
Ability to display excellent time management skills.
Ability to work in a dynamic, paced work environment.
Ability to communicate clearly and concisely with cross functional staff, members of management and external clients.
Less than 10% travel.
This position may require additional hours and/or weekend work.

Responsibilities

Responsible for scheduling and hosting client audits and coordinating audit responses for any deficiencies from internal stakeholders.
Responsible for follow-up and tracking of client audit observation commitments to assure timely closure.
Responsible for performing internal and audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports and coordinating audit responses for any deficiencies from internal stakeholders.
Responsible for follow-up and tracking of internal audit observations commitments to assure timely closure.
Responsible for reviewing and approving all audit responses to assure non-recurrence of deficiencies.
Maintain, trend, analyze and report quality metrics as it relates to internal and client audits.
Provide support and metrics for Quality Council meetings.
Provides support during FDA and other regulatory agency inspections
Writes and revises QA Standard Operating Procedures (SOP)
Support continuous improvement initiatives.
May be assigned to assist with supplier audits as needed.