Packaging Team Lead - days

Job Description

Job Description

Woodstock Sterile Solutions (WSS) is the leading North American blow-fill-seal (BFS) sterile contract development and manufacturing organization (CDMO). From our 430,000 sq ft advanced aseptic manufacturing facility in Woodstock, Illinois, we leverage 50+ years of BFS technology leadership and our patented cold BFS process to serve clients across ophthalmics, respiratory, biologics, and diagnostics markets. We are committed to Proven Excellence. Trusted Solutions.

Position Overview

The Packaging Team Lead oversees the packaging and inspection of pharmaceutical products in accordance with packaging instructions, SOPs, and current Good Manufacturing Practices (cGMP), while adhering to health and safety requirements. This role provides frontline leadership to Production Associates, ensuring the packaging line runs safely, efficiently, and in full compliance. This position is scheduled to work Thursday - Saturday and every other Wednesday, 5:45AM - 6:00PM, and is eligible for a $1/hour shift differential for the 12-hour shifts.

Key ResponsibilitiesPeople Leadership

• Provide leadership and direction to Production Associates in the inspection and labeling of product, delegating duties and ensuring operations are completed on time and per SOPs

• Perform on-the-job training as required

• Daily resource planning, including scheduling of Production Associates to lines

• Attend daily pass-down meetings at the start and end of every shift

• Provide break coverage for Production Associates as needed

Production Operations

• Perform packaging line start-ups, shutdowns, and clearances; ensure complete and accurate line set-up for each production lot

• Document all required clearance steps in the Packaging Work Order (PWO), following applicable SOPs

• Ensure adherence to the production schedule and identify discrepancies (sanitization, material handling, rework, units produced, downtime, etc.)

• Inspect product for defects and respond accordingly

• Coordinate and manage all off-line reworks

• Monitor MasterControl accounts to ensure Production Associates remain training-compliant

• Maintain a neat, orderly work area free of debris or extraneous items

• Inform production leadership of any product or equipment problems

Compliance & cGMP

• Conduct daily audits of cGMP paperwork completed by self and co-workers following sanitization activities, ensuring proper Good Documentation Practices (GDP)

• Always utilize safe work practices (proper bending/lifting techniques, chemical awareness, slip/trip/fall awareness, etc.)

• Maintain effectiveness of Quality System components relevant to the role

• Identify, evaluate, and manage risk to ensure product quality; communicate risk policies and processes throughout the organization

• Other duties as assigned

QualificationsEducation

• High school diploma or equivalent

Experience

• Minimum of one year of manufacturing experience, preferably pharmaceuticals

• Packaging operation experience beneficial

• Experience performing dimensional evaluations desired

• Functional testing experience desired

• Demonstrated leadership ability required

Knowledge, Skills & Abilities

• Familiarity with cGMP and safe work practices

• Proactive and willing to take initiative and responsibility

• High level of attention to detail

• Excellent documentation skills utilizing GDP, with the ability to review for accuracy and logic

• Strong problem-solving and analytical skills, incorporating basic mathematical and reasoning ability

• Works well in a team environment and fosters teamwork to get results

• Excellent verbal, written, and interpersonal communication skills, including direct interaction with outside suppliers, managers, and site leadership

• Computer literate with MS Office (Word/Excel/PowerPoint) and shop floor ERP & PSR systems (JDE preferred)

• Ability to interpret a variety of instructions in written, oral, diagram, or schedule form

• Comfortable meeting deadlines and working under pressure with limited supervision

• Demonstrated ability to read, write, and speak clear English

Physical Requirements

• Visual acuity of 20/30 (corrected)

• Ability to stand for up to 12 hours per day

• Frequent sitting, standing, walking, reaching, talking, listening, writing, handling, and grasping

• Occasional climbing of ladders/steps, walking inclines and uneven terrain, stooping, kneeling, crouching, bending, turning, balancing, and carrying

• Frequent lifting/moving up to 20 lbs; occasional lifting/moving up to 50 lbs

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.