Production Operator II

Manufacture process inspect document and package freeze-dried plasma products in a controlled cleanroom environment. Operate production equipment used to thaw transfer lyophilize and package plasma while maintaining product traceability and complying with current Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) approved procedures and safety requirements. Support production readiness and continuous improvement through procedure review accurate documentation and authorized redlining of production procedures.

Champion a safety-driven culture and comply with applicable safety environmental and occupational health requirements.
Manufacture process inspect and package product in accordance with approved procedures production records and established quality requirements.
Perform plasma-processing activities which may include retrieving frozen plasma operating thawing equipment transferring liquid plasma loading and unloading lyophilization equipment and repackaging finished product.
Operate applicable production equipment including balances/scales bag sealers thawers hoods lyophilizers computers label printers and glove boxes after required training and qualification.
Complete visual dimensional time label and documentation checks accurately and within established production standards.
Maintain complete and accurate product traceability and production records including timely data entry in the BECS system or other approved systems.
Identify and promptly report quality issues process deviations equipment concerns material defects or workmanship deficiencies in accordance with established procedures.
Comply with GMP and GDP requirements maintain required training records and follow approved manufacturing and quality system procedures.
Review procedures and provide documented improvement feedback or authorized redlines in accordance with document-control requirements.
Maintain a clean safe and organized work environment including adherence to gowning PPE contamination-control and housekeeping requirements.
Meet established quality productivity and labor-time expectations while maintaining compliance and product quality.
Cross-train on multiple product lines and assist with peer training on approved procedures and equipment when qualified and assigned.
Perform other duties as assigned.

High school diploma or equivalent strongly preferred.
At least 6 months of relevant experience in biologics pharmaceuticals medical devices or another highly regulated manufacturing environment required.

Working knowledge of GMP GDP and the importance of complete accurate and contemporaneous documentation.
Ability to read understand and follow policies procedures production records and processes written in English.
Ability to use computers and approved manufacturing systems for product tracking and data entry; experience with BECS or a similar system is preferred.

The pay range for this position at commencement of employment is expected to be between $20.38-28.55 per hour however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position will also include benefits such as medical prescription drug dental and vision insurance flexible spending accounts participation in 401(k) savings plan and various paid time off benefits such as PTO short- and long-term disability and parental leave dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.