Specialist II, Manufacturing (dayshift)

This position performs tasks in support of pharmaceutical manufacturing processes, including assisting with manufacturing investigations, document management, and maintaining team production metrics. The role provides oversight, execution, and approval for transactions in SAP and EDMS/QMS systems (Veeva) while ensuring OEE performance data is collected for each operating area.

Responsibilities

• Maintain advanced knowledge of the SAP system and execute SAP transactions to complete process orders.
• Coordinate daily and weekly activities to ensure the production schedule is met.
• Perform technical writing for investigations, line assessments, and corrective actions.
• Create, revise, and assist with preparation of documentation regarding activities, actions, and results using Good Documentation Practices (GDP).
• Communicate policies and procedures to employees.
• Establish visual tracking and tools to enhance audit readiness and trend analysis.
• Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
• Lead training on all document modifications prior to the effective date.
• Initiate appropriate action and report process deviations when they occur.
• Investigate manufacturing deviations; close out deviations, CAPAs, and/or AFCAs as needed.
• Review completed production documentation (e.g., batch records, log books) for quality, completeness, and cGMP compliance.
• Author, approve, review, revise, and audit SOPs, Work Instructions, and MBRs for cGMP manufacturing of commercial product.
• Coordinate cross-functionally with other departments as required.
• Alert supervisors/managers when problems occur outside of SOPs.
• Attend team meetings to discuss progress, initiatives, and other matters.
• Read, understand, and comply with cGMP and SOPs, including general safety and lockout procedures.
• Wear sterile garments and PPE (Personal Prote Equipment) as required by specific activities.
• Complete required training and duty-based packets by reading SOPs and technical documentation excerpts.
• Gather, organize, and communicate operational information to others.
• Lead process improvement activities and teams to meet strategic goals.
• Create training modules/resources to ensure SOPs are covered.
• Monitor key performance indicators to meet strategic goals.
• Monitor employee training to ensure compliance.
• Perform quality audits and walk-throughs (e.g., checking calibration tags, eye wash stations, labeling, floors).
• Attend inter-departmental meetings to coordinate multiple departments.
• Read technical publications/manuals and write associated procedures.

Requirements

• Experience in documentation in a cGMP environment.
• Experience in a pharmaceutical or cGMP-regulated environment.
• Ability to effectively understand, read, write, communicate, and follow instructions in English.
• Strong attention to detail; capable of keeping accurate records and performing mathematical calculations.

Qualifications

• Preferred: Experience in a production environment.
• High school graduate, vocational school graduate, or equivalent; Bachelor’s degree or equivalent preferred.
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.

Schedule

Dayshift, Monday–Friday, 8-hour days.

Pay

Target base pay hiring range: $28.50 – $43.00 per hour. Actual base pay depends on geographical location, relevant experience, qualifications, skills, and knowledge.

Benefits

• Robust total rewards program, including an annual cash bonus.
• 401(k) plan with a generous company match.
• Comprehensive healthcare (medical, dental, and vision).
• Family-building benefits.
• Life and disability insurance.
• Paid vacation, holidays, and other leaves of absence.
• Tuition reimbursement and support for caregiving needs.