Job Description

Job Location: Tamarac, FL 33321
Job Shift: DayJob Responsibilities:
•    Uses qualifications to perform process steps whenever necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
•    When necessary for continuous operations, assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
•    Performs daily review of batch documentation for accuracy and completeness.  At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review.
•    Ensures Operators monitor and document the critical process parameters during the manufacturing process.
•    Responds to and resolves process & equipment problems independently. Notifies Supervisors and works with other departments (Quality Assurance, Engineering, Technical Services, R&D, etc.) to facilitate resolution of issues.
•    Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications.
•    Acts as Subject Matter Expert on production procedures to support investigations, CAPAs, projects, new product introductions, and procedure generation and/or revision.
•    Monitors production schedules. Troubleshoots scheduling conflicts and coordinates Production resources and with other departments to meet production goals.
•    Trains new employees for new positions, processes, and retrains others as necessary.
•    Aids Section Leader in assigning qualified personnel as required to meet weekly production schedule including overtime scheduling as needed. Ensures personnel are properly trained and qualified before assigning tasks.
•    Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
•    Ensures housekeeping standards are followed and area is maintained during shift.
•    Follows all departmental and company safety policies in order to prevent injury to self and others.
•    Backfills associates in the processing rooms as needed.
•    Trains and audits production employees to ensure current approved SOP’s are followed.
•    Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.
•    Performs other duties in order to meet department's production schedule or to comply with cGMPs.
•    Works as a member of the team to achieve all outcomes.
•    Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
•    Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
•    Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned.
•    Works as a member of the team to achieve all outcomes.

Qualifications
- Education
- Batchelor’s Degree in Pharmaceutical Sciences, Engineering or closely allied life sciences discipline.
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- - - - Knowledge, Skills and Abilities
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- - - - Ability to lead by establishing and providing clear goals, direction, motivation, clarity, and support needed for self and others to excel in a continuous improvement culture.
- - - - Ability to organize and distribute work appropriately in an environment requiring strict adherence to timelines.
- - - - Demonstrates leadership experience particularly in the areas of approachability, dealing with direct reports, managing diversity, setting goals and objectives and measuring performance.
- - - - Use the appropriate amount of analysis, experience and judgement to make clear/concise decisions and experience in systematic problem solving.
- - - - Capacity and tact to address performance of direct reports and provide constructive feedback in a firm and timely manner.
- - - - Computer literacy with Microsoft office programs and exposure to JDE or other ERPs.
- - - - Ability to work within a diverse team environment (as part of a team) as demonstrated through previous work experience.
- - - - Excellent communication skills (written and spoken English) including strong verbal and interpersonal skills to lead and influence.
- - - - Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures.
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- Experience
- - 4+ years’ experience in a fast-paced, Lean Manufacturing environment required. Experience in a GMP environment preferred (pharmaceutical manufacturing/ biotechnology).
- - 3+ years experience in aseptic environments, sterile filling, or aseptic technique preferred.
- - 3+ years experience with Blow-Fill-Seal (BFS) manufacturing highly preferred.
- - Must be able to fluently read, write and speak in English.