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.
SUMMARY
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 completed orders and orders in process to ensure compliance with cGMP's and customer requirements. 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 tobatch records. Initiating supplier non-conformance reports and effectuates material control. Prepares planned deviation requests when needed. Adherence to PCI and cGMP policies, procedures, rules and regulations. Attendance to work is an essential function of this job.
May perform duties of Quality Auditor as assigned by Supervisor/Manager.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE:
High school education and experience working in a cGMP environment. A college degree with a concentration in a scientific discipline is preferred. Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines. The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., TrackWise/Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus.
EQUAL OPPORTUNITY EMPLOYER/DISABLED/VETERANS
Join us and be part of building the bridge between life changing therapies and patients.
Equal 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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
