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.
SAMPLE COORDINATOR l JOB SUMMARY
The Sample Coordinator I is primary responsibility is supporting all routine activities of the QC Sample Management Group, including, reference standards, raw materials, in-process, finished product and stability sample(s) receipt, issuance and tracking. The Sample Coordinator l's additional areas of accountability include but are not limited to, general laboratory cleaning, cleaning of quality control glassware and ordering, receipt and stocking of quality control testing consumables
SAMPLE COORDINATOR l JOB DUTIES
- Actively partners with Quality Control Microbiology and Analytical testing functions to ensure completion of activities within required timelines are met.
- Performs QC inspection, sampling and testing coordination of incoming components and raw materials, including chemicals, biologicals and packaging / labeling materials in accordance with CGMP and procedural requirements.
- Supports activities related to inventory control, sample receipt, labeling, sample destructions, sample pulls and oversight of sample deliveries, etc.
- Revise(s) technical documentation (e.g. SOPs, policies, forms, etc.) as required.
- Actively engages in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies.
- Performs/documents receipt and issuance of reference standards and in-process, finished product and stability samples.
- Logging and tracking of samples and chemicals. Order chemicals and laboratory supplies as needed. Performs general laboratory cleaning and cleaning of glassware.
- Assists with stability pulls and stability set downs as needed.
- Other duties, as needed
PROFESSIONAL SKILLS
- Excellent organizational skills
- Proficient in MS Office.
- Must have strong attention to detail as well as ability to work in a cross-functional team environment
EXPERIENCE
- 2 years experience in a cGMP organization
- QC experience preferred.
- Ability to work independently and in compliance with cGMPs.
EDUCATION
- High School Diploma with 1 or more years' experience in a CGMP environment, or a bachelor's degree in a scientific field with no experience.
QUALITIES
- Excellent interpersonal skills and the ability to communicate well both orally and in in writing
- Ability to multi-task in a dynamic environment with changing priorities
- Resilient, can quickly move forward despite challenges
- Ability to work independently
- Strong attention to detail and cross functional team experience.
- Positive attitude with demonstrated ability to work in a team environment
- Honesty, integrity, respect and courtesy with leadership and peers
- Strong commitment to conducting LSNE business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
- Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.
- Capacity to work on several tasks simultaneously.
- Able to organize and prioritize work activities.
- Must be able to walk and drive between locations
- Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
- Comfortable with working/handling of hazardous materials
COMMUNICATIONS & CONTACTS
- Works closely with the Quality Control organization in performing varied activities.
- Interacts with all departmental staff to coordinate activities.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
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.