Quality Control Coordinator

Quality Control CoordinatorThe Quality Coordinator assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.Essential Duties and Responsibilities:Prepares and distributes required documentation for requested production work orders.Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements.Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications.Prepares customer required samples for shipment according to approved shipping instructions.Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.Organize internal and customer approval of batch records and specs.Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements.Perform Line Clearance inspections of equipment and production suites.Help identify, communicate, track and resolve document related issues with other departments and customers.Function as one of the customer points for comments or questions pertaining to batch records.Initiating supplier non-conformance reports and effectuates material control.Reviews and integrates planned deviation requests into batch records when needed.Adherence to PCI and cGMP policies, procedures, rules and regulations.Attendance to work is an essential function of this job.May perform label creation duties including generating computerized labels.May perform duties of Quality Auditor as assigned by Supervisor/Manager.Other duties as assigned by Supervisor/Manager.Shift is Monday through Friday 8:00 am to 5:00 pm.Qualifications:Required:High School Diploma or GED1-3 years related experience and/or training.Basic Mathematical SkillsIntermediate 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.Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.High Standard of Report WritingPreferred:Ability to follow instructions and respond to management direction.Ability to work independently and/or part of a team.Ability to display excellent time management skills.Ability to demonstrate attention to detail.A college degree with a concentration in a scientific discipline is preferred.The candidate must be able to demonstrate basic proficiency with computers, business software (e.g. MS Office) and technical software (e.g. Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus.For Illinois residents: the hiring rate for this position is $18.15 to $20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).Equal Opportunity Employer/Vet/DisabledJoin us and be part of building the bridge between life changing therapies and patients. Let's talk futureEqual Employment Opportunity (EEO) Statement: 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 and Inclusion 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.